MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2015-04-24 for LIFEVEST WCD 4000 SYSTEM NA manufactured by Zoll Manufacturing Corporation.
[5583187]
During a retroactive review of past treatment events for potential adverse events, conducted as a capa in response to a recent fda inspection, a reportable adverse event was discovered. A (b)(6) yr old female patient contacted zoll customer support to report that a treatment had been delivered while she was exercising. Review of the event indicates that the patient experienced an inappropriate defibrillation. Motion artifact contributed to the false detection. The patient reportedly was attempting to respond to the alarms. Review of the downloaded data indicates that the response buttons were pressed after the treatment was delivered. The patient visited the er and continued use of the lifevest.
Patient Sequence No: 1, Text Type: D, B5
[13262278]
There was no death or device malfunction associated with the inappropriate defibrillation event. Device evaluation summary: device evaluation of monitor sn (b)(4) and belt sn (b)(4) was completed. The monitor and electrode belt were fully functional and able to detect and treat. Device manufacture date: electrode belt: 04/2013. Inappropriate defibrillations are an anticipated risk associated with the use of the lifevest. Patients are instructed through alarms, voice messages, ifu, and training to press the response buttons to prevent an inappropriate defibrillation. (b)(6). A summary of the safety and effectiveness data (ssed), including the inappropriate defibrillation safety objective supporting fda's approval of the lifevest, can be found at http://www. Accessdata. Fda. Gov/cdrh_docs/pdf/p010030b. Pdf.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008642652-2015-02400 |
| MDR Report Key | 4734448 |
| Report Source | 00 |
| Date Received | 2015-04-24 |
| Date of Report | 2015-04-16 |
| Date of Event | 2014-05-04 |
| Date Mfgr Received | 2015-04-09 |
| Device Manufacturer Date | 2013-04-01 |
| Date Added to Maude | 2015-04-29 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KATELYN MAINS |
| Manufacturer Street | 121 GAMMA DR |
| Manufacturer City | PITTSBURGH PA 152383495 |
| Manufacturer Country | US |
| Manufacturer Postal | 152383495 |
| Manufacturer Phone | 4129683333 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIFEVEST WCD 4000 SYSTEM |
| Generic Name | WEARABLE CARDIOVERTER DEFIBRILLATOR |
| Product Code | NVK |
| Date Received | 2015-04-24 |
| Model Number | WCD 4000 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZOLL MANUFACTURING CORPORATION |
| Manufacturer Address | PITTSBURGH PA 15238349 US 15238 3495 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2015-04-24 |