iNX 0015802Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00190790000011), received between Aug 24, 2016 and Mar 29, 2022 — classified as 1 death, 1 injury.

The most frequently reported specific device problem is “Battery Impedance Issue” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 29, 2022No Apparent Adverse Event; No Apparent Adverse Event

  THE MANUFACTURER HAS BEEN RECENTLY MADE AWARE OF A POTENTIAL INJURY ASSOCIATED WITH A PREVIOUSLY REPORTED MOTOR VEHICLE ACCIDENT. NO SPECIFIC DETAILS HAVE BEEN PROVIDED. THE MVA WAS INITIALLY REPORTED TO THE DEVICE MANUFACTURER ON 9/10/2021, HOWEVER; THERE WAS NO REPORT OF INJURY AT THAT TIME.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13937581 ↗
• DeathFeb 1, 2017Device Slipped; Battery Impedance Issue; Device Slipped

  IT WAS REPORTED MEDICS WERE CALLED TO A RESIDENCE FOR A NON-RESPONSIVE FEMALE. WHEN THE MEDICS ATTEMPTED TO UNLOAD THE STRETCHER FROM THE AMBULANCE TO TRANSPORT THE PATIENT TO THE HOSPITAL THE POWER MODE WOULD ALLEGEDLY NOT OPERATE DUE TO DEAD BATTERIES. THE CREW DID NOT ATTEMPT TO USE THE MANUAL MODE BUT RATHER CALLED A SECONDARY UNIT TO COMPLETE THE TRANSFER. COMPLAINANT ADVISED THE DELAY DID NOT HINDER THEIR ABILITY TO CARE FOR THE PATIENT AND DID NOT AFFECT THE OUTCOME OF THE PATIENT AS SHE WAS ALREADY IN FULL CARDIAC ARREST AND BEYOND RESUSCITATION UPON THEIR ARRIVAL TO THE SCENE. UPON ARRIVAL TO THE HOSPITAL THE PATIENT WAS DECLARED DECEASED. THE COT WAS REMOVED FROM SERVICE AND THE COMPANY MECHANIC VERIFIED THE ICS CHARGING SYSTEM IN THE AMBULANCE WAS WORKING CORRECTLY. THIS INCIDENT WILL BE INVESTIGATED AND THE BATTERIES INVOLVED WILL BE EVALUATED.

  Patient problems: Death

  MAUDE report 6294352 ↗
• Aug 24, 2016Break; Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated

  IT WAS REPORTED BY A COMPANY REPRESENTATIVE THE END USER OF THE COT EXPERIENCED AN INCIDENT DURING A PATIENT TRANSPORT. WHILE LOADING THE PATIENT INTO THE AMBULANCE, THEY RAISED THE FRONT WHEELS AND ALLEGEDLY HEARD A CRACKING SOUND AND THE COT ALLEGEDLY DROPPED 3-6 INCHES WHILE RESTING ON THE TRUCK FLOOR. THEY REMOVED THE COT FROM THE TRUCK AND OBSERVED THE RETRACTING HEAD END FRAME WAS BROKEN. THERE WERE NO REPORTS OF ANY INJURY ON THE INITIAL COMPLAINT; HOWEVER, 3 DAYS AFTER THE INITIAL REPORT IT WAS ADVISED THAT A MEDIC WAS ALLEGING A SHOULDER INJURY. TO DATE THE COMPLAINANT HAS NOT PROVIDED ANY FURTHER DETAILS REGARDING THE ALLEGED INJURY OR ANY REQUIRED MEDICAL INTERVENTION. AN INVESTIGATION INTO THIS COMPLAINT HAS BEEN INITIATED AND THE SUBJECT COT WILL BE RETURNED TO THE MANUFACTURER FOR FURTHER EVALUATION.

  Patient problems: Injury

  MAUDE report 5899814 ↗