MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2015-02-26 for LIFEVEST WCD 3000 SYSTEM NA manufactured by Zoll Manufacturing Corporation.
[5549819]
A zoll distributor returned electrode belt sn (b)(4) to report that the belt could not communicate with a monitor.
Patient Sequence No: 1, Text Type: D, B5
[12951769]
Device evaluation summary: device evaluation of electrode belt sn (b)(4) has been completed. The reported problem (does not communicate with a monitor) has been confirmed. As received, the belt failed incoming functionality testing. Upon investigation the electrode belt has bent trunk cable connector pins. The root cause for the bent pins could not be positively identified but was likely excessive force when connecting the electrode belt to a monitor. No adverse event resulted from the defective electrode belt.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008642652-2015-01032 |
| MDR Report Key | 4568517 |
| Report Source | 08 |
| Date Received | 2015-02-26 |
| Date of Report | 2015-02-26 |
| Date of Event | 2015-02-04 |
| Date Mfgr Received | 2015-02-24 |
| Device Manufacturer Date | 2013-01-01 |
| Date Added to Maude | 2015-04-02 |
| 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 3000 SYSTEM |
| Generic Name | WEARABEL CARDIOVERTER DEFIBRILLATOR |
| Product Code | NVK |
| Date Received | 2015-02-26 |
| Returned To Mfg | 2015-02-04 |
| Model Number | WCD 3000 |
| 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 | 2015-02-26 |