MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2015-03-30 for LIFEVEST WCD 4000 SYSTEM NA manufactured by Zoll Manufacturing Corporation.
[15350395]
A us distributor contacted zoll to report that electrode belt sn (b)(4) was unable to perform the detect and treat test.
Patient Sequence No: 1, Text Type: D, B5
[15746672]
Device evaluation summary. Device evaluation of electrode belt sn (b)(4) is complete. The reported problem (unable to perform detect and treat) was confirmed. As received, the electrode belt failed incoming testing. Upon investigation, the cable connecting the distribution node (dn) to rear therapy pad (te) was pulled from the strain relief. The cause of the test failure was the pulled dn to rear te cable. The root cause of the pulled dn to rear te cable cannot be positively identified. No adverse event resulted from the defective electrode belt.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008642652-2015-01636 |
| MDR Report Key | 4650036 |
| Report Source | 08 |
| Date Received | 2015-03-30 |
| Date of Report | 2015-03-25 |
| Date of Event | 2015-03-09 |
| Date Mfgr Received | 2015-03-11 |
| Device Manufacturer Date | 2014-04-01 |
| Date Added to Maude | 2015-05-11 |
| 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 | NINA RUDOLPH |
| Manufacturer Street | 121 GAMMA DR |
| Manufacturer City | PITTSBURGH PA 152383495 |
| Manufacturer Country | US |
| Manufacturer Postal | 152383495 |
| Manufacturer Phone | 4129683333 |
| 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 | NVK |
| Date Received | 2015-03-30 |
| Returned To Mfg | 2015-03-09 |
| 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 | 2015-03-30 |