FDA Adverse Event
Malfunction
Summary report: N
KINAIR
MDR report key: 1587214
·
Received January 8, 2010
Report
- Report Number
- 1625774-2010-00002
- Event Type
- Malfunction
- Date Received
- January 8, 2010
- Date of Event
- December 11, 2009
- Report Date
- December 11, 2009
- 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
KCI RECORDS INDICATE THAT THE KINAIR MEDSURG BED WAS INITIALLY PLACED WITH THE ACCOUNT ON (B)(6)2009. THE KINAIR MEDSURG POWER CORD WAS INSPECTED FOR DAMAGE ON (B)(6)2009, PRIOR TO PLACEMENT AT THE HEALTHCARE FACILITY. A SERVICE WORK ORDER WAS CREATED AND THE POWER CORD WAS REPLACED. NO OTHER COMPLICATIONS WERE REPORTED. EVALUATION OF THE RETURNED POWER CORD CONFIRMED THAT THE LINE IN PRONG WAS MISSING AND REVEALED EVIDENCE THAT MELTING HAD OCCURRED WHERE THE LINE IN PRONG HAD BEEN.
Description of Event or Problem · 1
ON 12/11/09, IT WAS REPORTED THAT ARCING ALLEGEDLY OCCURRED AT THE POWER CORD WHILE PLUGGED INTO THE WALL OUTLET AT THE HEALTHCARE FACILITY. THERE WAS NO INJURY TO THE PATIENT OR HEALTHCARE FACILITY STAFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KINAIR | IOQ | KCI USA, INC. | MEDSURG | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |