D
Patient 1
THERE WAS HEAT DAMAGE TO THE TRAY OF AN OLYMPIC WARM SCALE (OLYMPIC SMART SCALE, MODEL 23/28). THERE WAS NO PATIENT INJURY BECAUSE NO PATIENT WAS IN THE SCALE AT THE TIME OF TRAY DAMAGE.
MAUDE MDR 977600
- MDR report key
- 977600
- Report number
- 3018859-2008-00001
- Event key
- 0
- Event type
- 3
- Date of event
- 2007-12-11
- Date received
- 2008-01-08
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 401
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Address
- 5900 FIRST AVE., SOUTH SEATTLE WA 98108 US
- Phone
- 800-800-8004
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | OLYMPIC WARM SCALE (SMART SCALE, MODEL 23/28) | PATIENT SCALE (FRW) | OLYMPIC MEDICAL, A DIVISION OF NATUS MEDICAL | FRW | 28 | 56328 | NA | N | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2008-01-08 | 0 |
Event Narratives#
N
Patient 1
EVALUATION SUMMARY & CORRECTIVE ACTIONS: THE WARM SCALE WAS RETURNED TO OLYMPIC MEDICAL FOR INVESTIGATION. IT WAS DETERMINED THAT THE HEATER COIL WAS NOT EVENLY SPACED. AS A RESULT, A PORTION OF THE COIL SAGGED AND ELECTRICALLY SHORTED OUT AGAINST THE HEATER ENCLOSURE. THIS GENERATED A HOT SPOT IN THE HEATER COIL; THE ADDITIONAL HEAT CAUSED TRAY DAMAGE. AS PART OF THE EVALUATION, THE SAGGING, SHORTING AND OVERHEATING WAS REPEATED ON THE CUSTOMER'S DEVICE. NOTE THAT THE DEVICE WAS JUST BEYOND ITS USEFUL LIFE. IT WAS SHIPPED ON 11/30/98 AND HAD A PRODUCT LIFE OF 9 YEARS, SO ITS END OF LIFE WAS 11/30/07; THE INCIDENT OCCURRED IN LATE 2007. A CORRECTIVE AND PREVENTATIVE ACTION (CAPA) HAS BEEN OPENED TO INVESTIGATE POTENTIAL CORRECTIVE ACTIONS. THIS WILL INCLUDE A NOTIFICATION SENT TO ALL CUSTOMERS TO CHECK THE HEATER COIL FOR UNEVEN SPACING AND/OR SAGGING IN THEIR WARM SCALES; IF THEY HAVE ANY SCALES WITH A BUNCHED, STRETCHED, UNEVEN OR SAGGING HEATER COIL, THEY SHOULD RETURN THE SCALE TO OLYMPIC MEDICAL FOR SERVICE. THE CAPA WILL ALSO ADDRESS A MODIFICATION TO THE INSTRUCTION MANUAL TO INCLUDE ANNUAL INSPECTION OF THE HEATER COILS IN ADDITION TO INSPECTION FOLLOWING SERVICE OF THE HEATER. FINALLY, THE CAPA WILL INVESTIGATE POSSIBLE MODIFICATIONS TO THE DEVICE ITSELF.