MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-10-08 for WARM SCALE 500111-503 manufactured by Natus Medical Incorporated.
[3943585]
Warm-scale w/tray device was reported to have a melted tray. There was no smoke, no fire, no injuries. No patient/user involvement. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11241134]
The warm scale user manual requires annual cleaning of the heater assembly, and cleaning of the inlet filter every 6 months, or more frequently as required. Based on the amount of dirt and lint in the heater assembly, the unit had not been cleaned for some time, it is unknown when the last cleaning took place. Scale was also missing the filter, which allowed excessive dust and lint into the heater assembly and likely accelerated the problem. The manual also requires annual warmer cal. It is not known if this was done, however, the steady-state temperature from testing indicates that the unit had been changed from the factory settings. The calibration set points, as received from the customer and after cleaning the heater assembly, are about 6 degrees too high. Local temperatures at the heater outlet caused by low airflow due to obstruction are the cause of the deformed tray plastic. Additionally, the customer tray was broken in two different places which caused the tray to be misaligned with the heater assembly output vent. After performing the investigation detailed below, it is evident that the scale was not maintained according to the user manual, and as a result produced excessive temperatures at the heater output vent, which deformed the tray material.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3018859-2013-00009 |
| MDR Report Key | 3459120 |
| Report Source | 07 |
| Date Received | 2013-10-08 |
| Date of Report | 2013-10-08 |
| Date Mfgr Received | 2013-09-10 |
| Device Manufacturer Date | 2007-09-01 |
| Date Added to Maude | 2014-01-09 |
| 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 |
| Health Professional | 0 |
| 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 | 2062685156 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WARM SCALE |
| Generic Name | SMART SCALE |
| Product Code | FRW |
| Date Received | 2013-10-08 |
| Returned To Mfg | 2013-10-01 |
| Model Number | 500111-503 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MEDICAL INCORPORATED |
| Manufacturer Address | SEATTLE WA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-10-08 |