MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-09-10 for WARM-SCALE W/TRAY 120V/60 56323 manufactured by Natus Medical Incorporated.
[17445953]
Warm-scale w/tray device was reported to have a melted tray. There was no smoke, no fire no injuries. No pt/user involvement. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[17753909]
Customer facility contacted natus on (b)(6) 2013 stating that the warm scale tray is melting. Customer wanted to try calibrating the scale to verify the heat was properly adjusted, and said will call back with info. There was no call from the customer, so natus attempted to contact the facility on (b)(4) 2013, but there was no response. A voice mail was left requesting further info. On (b)(4) 2013, natus called the hospital for the 2nd time, and the person on the phone said the technician who originally reported the failure was not available, and that the "floor" did not make any reports about this, or similar issues. Natus has no further info at this time, and the device is not available for investigation. If new info becomes available, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3018859-2013-00008 |
| MDR Report Key | 3381285 |
| Report Source | 07 |
| Date Received | 2013-09-10 |
| Date of Report | 2013-09-09 |
| Date Mfgr Received | 2013-08-12 |
| Device Manufacturer Date | 2010-12-01 |
| Date Added to Maude | 2013-12-09 |
| 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 | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WARM-SCALE W/TRAY 120V/60 |
| Generic Name | SMART SCALE |
| Product Code | FRW |
| Date Received | 2013-09-10 |
| Model Number | 56323 |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2013-09-10 |