MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-29 for STERILE-DRIER 44 54344-M320 manufactured by Natus Medical Incorporated.
[49238455]
Natus medical incorporated is continuing to investigate this event in order to determine the root cause of the failure. Natus is attempting to return device for evaluation, at this time it is unknown if device will return as requested by natus. A follow up report will be submitted if failed device is returned for evaluation or any additional information obtained to complete investigation. Unknown if device will be returned.
Patient Sequence No: 1, Text Type: N, H10
[49238456]
Customer called and stated that sterile drier 44 device failed and caused a spark which caused considerable burns inside the dryer. Photos provided by the customer show evidence of abnormal heat in upper compartment which melted styrofoam; however photos revealed no indication of fire or burns in the vicinity.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2016-00002 |
| MDR Report Key | 5760624 |
| Date Received | 2016-06-29 |
| Date of Report | 2016-06-29 |
| Date Mfgr Received | 2016-06-01 |
| Device Manufacturer Date | 2012-02-24 |
| Date Added to Maude | 2016-06-29 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SVETLANA ROMANETS |
| Manufacturer Street | 5900 FIRST AVENUE SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal | 98108 |
| Manufacturer Phone | 2062685170 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | STERILE-DRIER 44 |
| Generic Name | STERILE-DRIER 44 |
| Product Code | LDS |
| Date Received | 2016-06-29 |
| Model Number | 54344-M320 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| 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 | 2016-06-29 |