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) 56323 manufactured by Olympic Medical, A Division Of Natus Medical.
[745458]
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. No specific date for the heat damage event was provided. The scale was received for repairs on june 8, 2007. At the time this incident was reviewed, the device damage was determined to be caused by improper servicing and insufficient maintenance. However, this case was reviewed again in light of mdr manufacturing report #3018859-2008-00001 to be reportable by mdr.
Patient Sequence No: 1, Text Type: D, B5
[7932155]
Evaluation summary & corrective action: the warm scale was returned to olympic medical for repair. It was determined that the heater coil was stretched out due to improper service; the heater was removed and stretched during hospital service. The stretched portion of the heater coil was nearest to the over-temperature thermistor sensor assembly; this resulted in overheating and damage to the tray. Note that the device was beyond its useful life. It was shipped on 2/25/98 and had a product life of 9 years so its end of life was 2/25/07; the incident occurred in approximately may of 2007. More importantly, the problem could have been detected earlier with annual heater calibration checks as specified in the instruction manual. However, no heater calibration checks were performed during the lifetime of the device. As part of mdr manufacturer report #3018859-2008-00001, a notification is being sent to all warm scale 23/28 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. This customer notification will also include a reminder to perform annual heater calibration as provided in the instruction manual.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3018859-2008-00002 |
| MDR Report Key | 977599 |
| Report Source | 05,06 |
| Date Received | 2008-01-08 |
| Date of Report | 2008-01-08 |
| Date Mfgr Received | 2007-12-11 |
| Device Manufacturer Date | 1998-02-25 |
| Date Added to Maude | 2008-09-29 |
| 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 | 2007-06-08 |
| Model Number | 23 |
| Catalog Number | 56323 |
| 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 | 980540 |
| Manufacturer | OLYMPIC MEDICAL, A DIVISION OF NATUS MEDICAL |
| Manufacturer Address | SEATTLE WA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-01-08 |