Why Medical Devices Malfunction and What To Do

A medical device malfunction that results in physical injury, revision surgery, or financial strain requires reporting and possibly litigation. The term ‘medical device’ can apply to equipment, like a heart rate monitor, as well as a personal device, like a sleep apnea apparatus, arterial stent, insulin pump, or joint implant.

If you or a loved one relies on medical equipment to regulate essential functions or to enjoy a better quality of life, you should understand what constitutes a device failure, how these happen, and what steps to take if an adverse medical event occurs.

Types of Malfunctions

Medical devices include instruments used to treat, monitor, or diagnose a patient, and components used to correct a physical condition. A ‘malfunction’ usually refers to a device that stopped working in some capacity or failed in some manner, but the term also applies to components deemed unsafe or contaminated.

These examples illustrate the range of medical device malfunctions:

• Hip and knee replacements loosening or failing
• Surgical mesh causing complications like infections or organ damage
• Insulin pumps delivering incorrect dosages
• Pacemakers and defibrillators can malfunction, leading to life-threatening cardiac events 
• Malfunctions in surgical tools can lead to errors during procedures, including accidental damage to organs or nerves

Causes of Medical Device Malfunctions

Inadequate Testing

Medical device testing may be fast tracked due to a manufacturer’s eagerness to bring an item to market or an incorrect assumption that it is ‘similar enough’ to another product. To prevent defective products from reaching consumers, medical device laws require manufacturers to test the product function and packaging, but the rigor of this practice depends on the product class. Testing can be delayed or reduced due to tight timelines or resource shortages. Rushing approvals allows certain weaknesses and failure points to be undertested and remain unnoticed until it is too late.

Lacking Quality Control

Developing a robust quality control system is expensive and time-consuming, and some manufacturers would rather risk backtracking or recalls later in favor of being first to market. This practice leaves patients at risk of receiving a faulty device. Inadequate quality control can result in single products slipping through the process or entire batches of faulty devices hitting the market. Both situations jeopardize public safety and introduce challenges to identifying and removing faulty items from use.

Low-Quality Components

Medical device companies strive to profit, which may influence the materials, coatings, and adhesives they select for use in finished devices. Supply-chain issues and availability may also affect which parts a device maker prefers. Lower-quality materials or components can cause a device to degrade quickly or underperform once implanted into a patient’s body.

Errors in Service Manuals and Instructions

Errors or omissions in service manuals and instructions can impact how a person uses and maintains a medical device. If a manufacturer neglects to advise consumers to use proprietary cables and accessories or perform routine maintenance, or fails to warn them of the hazards of reusing single-use components, patients could unknowingly damage the equipment and cause its malfunction. When a device’s monitoring capacity or functionality is reduced due to incorrect servicing, the patient could experience severe injury or death.

Actions After a Device Failure

Reporting suspected medical device failures is essential to prevent users from injury. Occasionally a defect may appear in only a handful of items on the market, but sometimes hundreds or thousands of items may be affected by the engineering, packaging, or design defect. Reporting any adverse reaction to your healthcare provider, the Food and Drug Administration (FDA), and the manufacturer can help save others from harm and inform your next steps.

Alert Your Healthcare Provider

Anyone relying on a medical device must alert a healthcare professional to possible malfunctions right away. This ensures you’ll receive the right care until the device is corrected or replaced. Healthcare providers may voluntarily report this information to oversight agencies and the manufacturer, which will help safety officials decide whether a recall or other action is necessary.

Report the Malfunction to the FDA

The FDA receives two million reports of device malfunctions per year, and many of them are suspected of causing deaths and serious injuries. This agency oversees medical device issues, including recalls for defective equipment. Manufacturers are required to report adverse events related to their products, but healthcare providers, patients, and caregivers may voluntarily inform the FDA of potential medical device safety issues to help authorities identify harmful products. The FDA may then issue a recall to alert others who have received the device to potential issues, which can also reduce out-of-pocket expenses for related medical corrections.

Take Legal Action

Evidence that the manufacturer’s engineering, design, packaging, or instructions caused a device’s harmful malfunction, may be grounds for a lawsuit. Taking legal action improves awareness of faulty equipment and can help you receive the resources you need to recover from additional treatments, corrective surgeries, and associated financial losses.

When the manufacturer is responsible for a malfunctioning medical device, a product liability lawsuit can hold them accountable for producing it. If a healthcare provider improperly handles a recall, the physician and the hospital or surgical center may be held liable in a medical malpractice lawsuit.

Sorting out which medical device laws apply for defects and which lawsuit to file isn’t easy. Bell Legal Group is here to help. Share your story with us and we’ll determine the best course of action to bring you the resolution you deserve.