AERO Z
Received Aug 27, 2018 · Event occurred Aug 14, 2018
Report 3032618-2018-00006 · MDR key 7820455
Device
Product problems
- Break
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
NO INJURY WAS REPORTED IN THIS EVENT. THERE IS A RISK OF SERIOUS INJURY IN THE CASE OF A FAILURE OF THE ANTI-TIPS WHILE ENGAGED. THE RETURNED SAMPLES OF THE ANTI-TIPS WERE TESTED, ALONG WITH SAMPLES FROM THE THEN-CURRENT LOT AND OF A DIFFERENT LOT. THE RESULTS OF A COMBINATION OF INTERNAL AND EXTERNAL/THIRD-PARTY TESTING INDICATES THAT THE MATERIAL OF THE ANTI-TIP TUBE USED ON THE CONSTRUCTION OF THIS CHAIR WAS SOFTER AND WEAKER THAN THE DESIGN SPECIFIED.
Description of Event or Problem
THE PROVIDER CLAIMS THE THERAPIST TESTED THE ANTI-TIPS BEFORE GETTING THE PATIENT IN, AND AS A RESULT OF THE TEST THE ANTI-TIP TUBES BENT.
Remedial action
- Replace