FDA Adverse Event
Malfunction
Summary report: N
KINAIR
MDR report key: 1619807
·
Received February 26, 2010
Report
- Report Number
- 1625774-2010-00019
- Event Type
- Malfunction
- Date Received
- February 26, 2010
- Date of Event
- January 28, 2010
- Report Date
- January 28, 2010
- Manufacturer
- KCI USA, INC.
- Product Code
- IOQ
- PMA / PMN Number
- EXEMPT
- Removal / Correction Number
- 1625774-10/28/2009-001-C
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURE ON (B)(6)2009, PRIOR TO DELIVERY TO THE ACCOUNT, AND MET SPECIFICATIONS. SUBSEQUENT TO THE REPORTED EVENT, THE KINAIR MEDSURGE BED AND ITS POWER CORD WERE RETURNED TO THE KCI SERVICE CENTER AND EVALUATED. EVAL OF THE KINAIR MEDSURGE POWER CORD CONFIRMED THAT THE NEUTRAL PRONG WAS MISSING AND REVEALED EVIDENCE THAT MELTING AND SCORCHING HAD OCCURRED. THE KINAIR MEDSURG BED WAS EVALUATED BY KCI SERVICE AND NO ADDITIONAL MALFUNCTION WAS FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE POWER CORD PLUG ALLEGEDLY MALFUNCTIONED WHILE AT THE HEALTHCARE FACILITY. THE KINAIR MEDSURG BED WAS INITIALLY PLACED WITH THE ACCOUNT ON (B)(6)2010. THERE WAS NO REPORT OF AN INJURY TO THE PT OR HEALTHCARE FACILITY STAFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KINAIR | IOQ | KCI USA, INC. | MERSURG | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |