MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-12-01 for WARM SCALE 23 56328 manufactured by Natus Medical Inc..
[94674675]
The device was returned to natus for factory service inspection/repair. The service testing did not show any issues other than an older battery that was replaced to allow for further testing. There is no indication that the battery failed early or prematurely. The device passed all quality assurance testing and has been returned to the customer per normal repair procedure.
Patient Sequence No: 1, Text Type: N, H10
[94674676]
A customer's biomed contacted natus technical service for the part number and pricing of the infant tray and shelf for the warm scale. When asked why replacements were required, the customer reported that the tray and the insert had melted areas. The customer went further to state that device was not in use with a patient when the issue was discovered and there were no environmental safety concerns. The customer stated that the clinical staff had been using the device to warm up a stack of cloths for patients. No death, harm or delay in patient procedures have been reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2017-00988 |
| MDR Report Key | 7077516 |
| Report Source | USER FACILITY |
| Date Received | 2017-12-01 |
| Date of Report | 2017-11-03 |
| Date Mfgr Received | 2017-11-03 |
| Device Manufacturer Date | 2010-11-04 |
| Date Added to Maude | 2017-12-01 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | JEFFREY MANTKOWSKI |
| Manufacturer Street | 5900 FIRST AVENUE SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal | 98108 |
| Manufacturer Phone | 2062685143 |
| Manufacturer G1 | NATUS MEDICAL INC. |
| Manufacturer Street | 5900 FIRST AVENUE SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 98108 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WARM SCALE 23 |
| Generic Name | WARM SCALE 23 |
| Product Code | FRW |
| Date Received | 2017-12-01 |
| Returned To Mfg | 2017-11-13 |
| Model Number | 56328 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MEDICAL INC. |
| Manufacturer Address | 5900 FIRST AVENUE SOUTH SEATTLE WA 98108 US 98108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-12-01 |