MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,07 report with the FDA on 2015-04-10 for LIFEVEST WCD 4000 SYSTEM NA manufactured by Zoll Manufacturing Corporation.
[17936774]
A retroactive review of pt flag files in the lifevest network identified multiple potential monitor resets following treatments on (b)(6) 2014. On (b)(6) 2014, the pt was waiting to receive an icd in the hospital at the time of the potential event. A physician assistant (pa) called into zoll and stated that the pt received a lower extremity ischemia. The pa fond the pt unconscious on the floor. The pt stated that he does not remember anything at all. The hospital staff did not report any events during this period. A retrospective review of the pt's flag files suggests the pt received 33 treatments from (b)(6) 2014 at 07:50:14 to (b)(6) 2014 at 13:39:03. The device properly detected four episodes of ventricular arrhythmia. Two were self-terminating and the status of the other two were unk due to monitor reset. False detections appear to be caused by multiple counting of tall t-waves. After each of the treatments, the monitor reset. The response buttons were pressed infrequently during the event. The pt received a replacement electrode belt. The pt ended use on (b)(6) 2014 because the pt received an icd.
Patient Sequence No: 1, Text Type: D, B5
[18392029]
(b)(4). The pt received a replacement electrode belt. The pt ended use on (b)(6) 2014 because the pt received an icd. Device evaluation summary: device evaluation of monitor sn (b)(4) and electrode belt sn (b)(4) were completed. The monitor and electrode belt were returned as routine maintenance and found to be fully functional. Zoll was unaware of the treatments and reset that occurred at that time and therefore there was no complaint was initially generated. An investigation into monitors exhibiting the same issue found that the root cause for the reset is noise from the defibrillator pca high-voltage capacitors propagating on the main battery wire on the monitor c/a board. A real-time review request for a design change to address this issue was submitted to fda on (b)(4) /2015. No adverse event resulted from the pulse reset. Device manufacture date: monitor sn (b)(4): 01/2014 - initial use. Electrode belt sn (b)(4): 11/2012 - reuse. Appropriate defibrillations are an anticipated risk associated with the use of the lifevest. Pts are instructed through alarms, voice messages, ifu, and training to press the response buttons to prevent an inappropriate defibrillation. (b)(4). 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 | 3008642652-2015-01730 |
| MDR Report Key | 4688721 |
| Report Source | 00,07 |
| Date Received | 2015-04-10 |
| Date of Report | 2015-04-10 |
| Date of Event | 2014-02-12 |
| Date Mfgr Received | 2015-03-13 |
| Device Manufacturer Date | 2014-01-01 |
| Date Added to Maude | 2015-05-21 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| 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 |
| 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 | 2015-04-10 |
| 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. Other | 2015-04-10 |