FDA Adverse Event
Other
Summary report: N
BED, AIR FLUIDIZED
MDR report key: 2018668
·
Received March 3, 2011
Report
- Report Number
- 1525712-2011-00077
- Event Type
- Other
- Date Received
- March 3, 2011
- Date of Event
- February 6, 2011
- Manufacturer
- KAP MEDICAL
- Product Code
- INX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
USER ALLEGES THEY HEARD A NOISE FROM THE POWER UNIT AND OBSERVED SMOKE FROM THE BACK OF THE UNIT. DEVICE HAS BEEN IN SVC FOR OVER TWO YEARS AND ITS UNK COMPLAINT IS A RESULT OF DROPPING DEVICE, MECHANICAL WEAR OR A MALFUNCTION. THE UNIT WAS UNPLUGGED AND TAKEN OUT OF SVC. FILING SOLELY ON THE USER'S ALLEGATION OF SMOKE MALFUNCTION IS NOT CONFIRMED. MFR IS ATTEMPTING TO OBTAIN PRODUCT FOR INSPECTION.
Description of Event or Problem · 1
THE CONSUMER'S FATHER ALLEGES HE HEARD A LOUD SCRAPING NOISE AND SAW SMOKE COMING FROM THE BACK OF THE POWER UNIT. NO INJURY IS ALLEGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BED, AIR FLUIDIZED | 890.5160 | INX | KAP MEDICAL | MA85 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 YR |