MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-09-21 for WARMETTE 56948 manufactured by Natus Medical Incorporated.
[88215271]
Both biomedical technicians in contact with tech support reported that there was heat damage apparent on the gasket between plenum (inside which are the heating elements) and blower. When airflow no longer flows to the plenum, heat will build in the plenum and gasket. The customer reported that the thermal cutout was not opened, which cause the heaters to disengage. The customer is instructed to test annually per the user manual 56948-ima-en0408o. A replacement part of the blower motor, a required component was sent due to normal wear and tear on the 11 year old product. Issue was resolved. No further evaluation is needed.
Patient Sequence No: 1, Text Type: N, H10
[88215272]
Natus medical received a complaint that on (b)(6) 2017 the warmette had a burning smell. The gasket between the warmette blower and plenum was deformed. Follow-up questionnaire on august 25th, 2017 biomedical technician responded that the "unit developed volumes of smoke inside of unit. " no reported injury or patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2017-00716 |
| MDR Report Key | 6884104 |
| Report Source | USER FACILITY |
| Date Received | 2017-09-21 |
| Date of Report | 2017-08-22 |
| Date Mfgr Received | 2017-08-22 |
| Device Manufacturer Date | 2006-04-09 |
| Date Added to Maude | 2017-09-21 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MARC RIVAS |
| Manufacturer Street | 5900 FIRST AVENUE SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal | 98108 |
| Manufacturer Phone | 2062685142 |
| Manufacturer G1 | NATUS MEDICAL INCORPORATED |
| Manufacturer Street | 5900 FIRST AVENUE SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 98108 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WARMETTE |
| Generic Name | WARMETTE |
| Product Code | LHC |
| Date Received | 2017-09-21 |
| Model Number | 56948 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MEDICAL INCORPORATED |
| Manufacturer Address | 5900 FIRST AVENUE SOUTH SEATTLE WA 98108 US 98108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-09-21 |