MalfunctionIOQ
AIR PLUS PUMP
Received Oct 28, 2024 · Event occurred Jul 1, 2024
Report 0001831750-2024-01224 · MDR key 20544807
Device
Generic name
Bed, Flotation Therapy, Powered
Manufacturer
Stryker Medical-kalamazooCatalog number
2863000000
Product problems
- Electrical /Electronic Property Problem
- Electrical /Electronic Property Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED ACCESSIBLE AC CURRENT. THERE WAS NO PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. 1 DEVICE WAS FUNCTIONALLY/VISUALLY INSPECTED IN THE FIELD. THE DEVICE WAS REPAIRED AND RETURNED TO USE. THERE WAS NO REMEDIAL ACTION TAKEN. THIS DEVICE IS NOT LABELED FOR SINGLE USE.