Description of Event or Problem · 0
I AM WRITING TO FORMALLY REPORT A DEFECTIVE MEDICAL DEVICE, THE LNOGEN GS PORTABLE OXYGEN CONCENTRATOR (POC), WHICH WAS PURCHASED FROM NATIONAL MEDICAL EQUIPMENT, INC. AND CAUSED SIGNIFICANT HARM TO MY HUSBAND'S HEALTH DURING ITS USE. THIS MATTER INVOLVES BOTH THE MALFUNCTION OF THE DEVICE AND THE COMPANY'S FAILURE TO ADEQUATELY ADDRESS THE SITUATION. BACKGROUND: ON (B)(6) 2024, I PURCHASED AN INOGEN GS POC FROM (B)(4) FOR (B)(6). THE DEVICE WAS REQUIRED TO FACILITATE THE SAFE AIR TRANSPORT OF MY HUSBAND, WHO HAD SUFFERED A CATASTROPHIC ACCIDENT AND WAS BEING TRANSFERRED FROM (B)(6) TO (B)(6) FOR CONTINUED MEDICAL CARE. THE DEVICE WAS REPRESENTED AS FAA-APPROVED AND CAPABLE OF FUNCTIONING FOR 13 HOURS, WHICH WAS CRITICAL FOR OUR 3-HOUR FLIGHT AND ANY POTENTIAL DELAYS. DEVICE FAILURE: SHORTLY AFTER TAKEOFF, THE INOGEN GS POC FAILED. THIS MALFUNCTION LEFT MY HUSBAND WITHOUT SUFFICIENT OXYGEN FOR OVER SEVEN HOURS DURING THE FLIGHT, RESULTING IN DELIRIUM AND A SIGNIFICANT WORSENING OF HIS ALREADY CRITICAL CONDITION. THE LACK OF OXYGEN DURING THIS PERIOD EXACERBATED HIS HEALTH PROBLEMS AND CAUSED IMMENSE DISTRESS. TRAGICALLY, HIS CONDITION DETERIORATED RAPIDLY FOLLOWING THIS INCIDENT, AND HE PASSED AWAY ON (B)(6) 2024. ISSUES WITH (B)(4): MISREPRESENTATION OF DEVICE CAPABILITIES: THE COMPANY ASSURED ME THE POC WOULD OPERATE FOR 13 HOURS, BUT IT FAILED WITHIN APPROXIMATELY 2.5 HOURS. FAILURE TO FILE (B)(6) CLAIM: DESPITE (B)(6) CONFIRMING THE DEVICE WOULD HAVE BEEN COVERED, THE COMPANY REQUIRED UPFRONT PAYMENT AND DID NOT PROCESS THE CLAIM. DEFECTIVE EQUIPMENT: THE DEVICE'S MALFUNCTION IN A LIFE-CRITICAL SITUATION RAISES QUESTIONS ABOUT ITS QUALITY AND SAFETY. INADEQUATE RESOLUTION: DESPITE RETURNING THE DEVICE PER THEIR INSTRUCTIONS, THE COMPANY INITIALLY REFUSED DELIVERY AND ONLY ACCEPTED IT AFTER A SECOND ATTEMPT. THEY OFFERED A NOMINAL REFUND OF (B)(6), FAR BELOW THE PURCHASE PRICE, AND FAILED TO PROVIDE ANY JUSTIFICATION OR ACCOUNTABILITY FOR THE DEFECTIVE PRODUCT. IMPACT: THE FAILURE OF THIS MEDICAL DEVICE HAD CATASTROPHIC CONSEQUENCES FOR MY HUSBAND'S HEALTH AND CONTRIBUTED TO HIS UNTIMELY PASSING. THIS SITUATION ALSO CAUSED EMOTIONAL AND FINANCIAL DISTRESS TO OUR FAMILY. ADDITIONALLY, THE COMPANY'S REFUSAL TO HONOR ITS COMMITMENTS HIGHLIGHTS BROADER CONCERNS ABOUT THEIR ETHICAL PRACTICES. REQUEST FOR FDA ACTION: I REQUEST THAT THE FDA INVESTIGATE THE FOLLOWING: DEVICE RELIABILITY: CONDUCT A THOROUGH REVIEW OF THE INOGEN GS POC TO DETERMINE WHETHER IT MEETS SAFETY AND PERFORMANCE STANDARDS. COMPANY PRACTICES: INVESTIGATE NATIONAL MEDICAL EQUIPMENT, INC. FOR POTENTIAL VIOLATIONS OF FDA REGULATIONS, INCLUDING THE DISTRIBUTION OF DEFECTIVE DEVICES AND MISREPRESENTATION OF PRODUCT CAPABILITIES. RECALL EVALUATION: ASSESS WHETHER THE INOGEN GS POC SHOULD BE SUBJECT TO A RECALL OR ADDITIONAL SCRUTINY TO PREVENT HARM TO OTHER PATIENTS. PLEASE FIND ATTACHED SUPPORTING DOCUMENTATION, INCLUDING: PROOF OF PURCHASE/SHIPPING AND RETURN DETAILS I APPRECIATE YOUR PROMPT ATTENTION TO THIS MATTER. ENSURING THE SAFETY AND RELIABILITY OF MEDICAL DEVICES IS VITAL TO PROTECTING PATIENTS AND THEIR FAMILIES FROM SIMILAR TRAGEDIES. THANK YOU FOR YOUR TIME AND CONSIDERATION. PLEASE DO NOT HESITATE TO CONTACT ME IF YOU REQUIRE ADDITIONAL INFORMATION OR DOCUMENTATION.