MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-31 for LIFEVEST WCD 4000 SYSTEM 10A0988 manufactured by Zoll Manufacturing Corporation.
[185952681]
Device evaluation of monitor sn (b)(4) has been completed. The reported problem (damaged case) has been confirmed. Upon investigation the monitor failed incoming functional testing. The monitor's electrode belt connector was broken free from the monitor enclosure, damaging wires within the connector. The root cause for the damaged connector was excessive force. No adverse event resulted from the defective monitor.
Patient Sequence No: 1, Text Type: N, H10
[185952682]
A us distributor reported that a patient's monitor case was damaged.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008642652-2020-02688 |
| MDR Report Key | 9902831 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-29 |
| Date of Event | 2020-02-10 |
| Date Mfgr Received | 2020-03-27 |
| Device Manufacturer Date | 2014-09-22 |
| Date Added to Maude | 2020-03-31 |
| 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 | ANNA BEATTY |
| Manufacturer Street | 121 GAMMA DRIVE |
| Manufacturer City | PITTSBURGH, PA |
| Manufacturer Country | US |
| Manufacturer Phone | 9683333 |
| Manufacturer G1 | ZOLL MANUFACTURING CORPORATION |
| Manufacturer Street | 121 GAMMA DRIVE |
| Manufacturer City | PITTSBURGH, PA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIFEVEST WCD 4000 SYSTEM |
| Generic Name | WEARABLE CARDIOVERTER DEFIBRILLATOR |
| Product Code | MVK |
| Date Received | 2020-03-31 |
| Returned To Mfg | 2020-03-02 |
| Model Number | WCD 4000 |
| Catalog Number | 10A0988 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZOLL MANUFACTURING CORPORATION |
| Manufacturer Address | 121 GAMMA DRIVE PITTSBURGH, PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |