MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-10 for ER920W WIRELESS EVENT RECORDER WEVENT manufactured by Braemar Manufacturing Llc.
[108288535]
The device was returned to braemar for evaluation on 04/17/2018. It is believed the cause of the battery malfunction will most likely not be able to be determined due to the damage to the battery and device. Upon review of 2018 and 2017 complaints, this was the second reported event in 2018. Previous to 2018 there were three similar events reported to the fda via mdrs 2133409-2016-00002, 2133409-2016-00003, and 2133409-2017-00001. (b)(4). An evaluation will be performed with an external failure analysis expert, and a supplemental mdr will be submitted with any new results. Prior to this reported event in early 2018, braemar has begun transitioning to a new rechargeable battery option to reduce the likelihood of future battery rupture events.
Patient Sequence No: 1, Text Type: N, H10
[108288536]
Braemar received information on 04/12/2018 from our distributor in which they reported an adverse incident involving one of the braemar er920w event recorders and a disposable lithium thionyl chloride battery. The distributor informed braemar a battery ruptured/exploded in the device in a patients home while the device was sitting on a table. No patient injury was reported. As the result of the review of photos received of the ruptured battery and resulting damage observed on the returned device, it was determined this event could be likely to cause or contribute to a serious event if it were to recur, and is therefore being reported to the fda per 21 cfr 803 as an mdr.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2133409-2018-00002 |
| MDR Report Key | 7502965 |
| Date Received | 2018-05-10 |
| Date of Report | 2018-04-12 |
| Date of Event | 2018-03-31 |
| Date Mfgr Received | 2018-09-04 |
| Device Manufacturer Date | 2017-01-10 |
| Date Added to Maude | 2018-05-10 |
| 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 | MR. DARREN DERSHEM |
| Manufacturer Street | 1285 CORPORATE CENTER DRIVE SUITE 150 |
| Manufacturer City | EAGAN MN 55121 |
| Manufacturer Country | US |
| Manufacturer Postal | 55121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ER920W WIRELESS EVENT RECORDER |
| Generic Name | WEVENT |
| Product Code | MLO |
| Date Received | 2018-05-10 |
| Returned To Mfg | 2018-04-17 |
| Model Number | WEVENT |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BRAEMAR MANUFACTURING LLC |
| Manufacturer Address | 1285 CORPORATE CENTER DRIVE SUITE 150 EAGAN MN 55121 US 55121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-10 |