MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-01-08 for OLYMPIC WARM SCALE (SMART SCALE, MODEL 23/28) 56328 manufactured by Olympic Medical, A Division Of Natus Medical.
[746031]
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.
Patient Sequence No: 1, Text Type: D, B5
[8087722]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3018859-2008-00001 |
| MDR Report Key | 977600 |
| Report Source | 05,06 |
| Date Received | 2008-01-08 |
| Date of Report | 2008-01-08 |
| Date of Event | 2007-12-11 |
| Date Mfgr Received | 2007-12-11 |
| Device Manufacturer Date | 1998-11-30 |
| Date Added to Maude | 2008-09-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 5900 FIRST AVE., SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal | 98108 |
| Manufacturer Phone | 8004260353 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPIC WARM SCALE (SMART SCALE, MODEL 23/28) |
| Generic Name | PATIENT SCALE (FRW) |
| Product Code | FRW |
| Date Received | 2008-01-08 |
| Returned To Mfg | 2007-12-21 |
| Model Number | 28 |
| Catalog Number | 56328 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 980525 |
| Manufacturer | OLYMPIC MEDICAL, A DIVISION OF NATUS MEDICAL |
| Manufacturer Address | SEATTLE WA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-01-08 |