FDA Adverse Event
Malfunction
Summary report: N
MIDMARK
MDR report key: 1946371
·
Received December 10, 2010
Report
- Report Number
- 1523530-2010-00014
- Event Type
- Malfunction
- Date Received
- December 10, 2010
- Date of Event
- November 19, 2010
- Report Date
- December 9, 2010
- Manufacturer
- MIDMARK CORP.
- Product Code
- FLE
- PMA / PMN Number
- K990189
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
WE HAVE REQUESTED THAT THE UNIT BE RETURNED FOR EVALUATION. AS OF THE DATE OF THIS REPORT, THE UNIT HAS NOT BEEN RECEIVED. FROM PHOTOGRAPHS OF THE PC BOARD, IT APPEARS THAT A SOLDER JOINT/RUN ON THE PRINTED CIRCUIT BOARD OVERHEATED CAUSING THE BOARD TO PARTIALLY MELT. THE MELTING PRODUCED THE SMOKE REPORTED BY THE USER. THE ROOT CAUSE OF THE FAILURE COULD NOT BE DETERMINED.
Description of Event or Problem · 1
MAX FROM NASHVILLE CALLED IN, AND SAID THAT THE PCB CAUGHT FIRE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MIDMARK | STEAM STERILIZER | FLE | MIDMARK CORP. | M11 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |