MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-30 for LIFEVEST WCD 4000 SYSTEM 10A0988 manufactured by Zoll Manufacturing Corporation.
[185570761]
Device evaluation summary: device evaluation of electrode belt sn (b)(4) has been completed. Upon investigation connectors j703 and j704 were pulled from the distribution node pca and broken. Additionally, the cables connecting ecg c and d and the ecg c and d electrode domes were missing. There is no indication that the damaged electrode belt caused or contributed to the patient's passing. Review of the patient's download data from the event does not indicate a product malfunction. The root cause for the damaged connectors could not be positively identified. Monitor sn (b)(4) has been returned to zoll manufacturing corporation but has not been evaluated yet. Device evaluation includes review of downloaded software flag files on the days surrounding the event. The review of the software flags consisted of an analysis of the downloaded data to identify any fault flags or unusual patterns of software flags. The software flag files did not suggest a device malfunction that would contribute to the patient treatment. Manufacture date: monitor - (b)(4) - 02/04/2013, belt - (b)(4) - 09/07/2015.
Patient Sequence No: 1, Text Type: N, H10
[185570762]
A us distributor contacted zoll to report that a patient experienced passed away on (b)(6) 2020. Review of the patient's download data reveals that the patient experienced a defibrillation event consisting of four shocks on (b)(6) 2020 and (b)(6) 2020. At 12:34:53 on (b)(6) 2020, the lifevest detected ventricular tachycardia (vt) and delivered an appropriate treatment. The patient's post-shock rhythm was sinus bradycardia at 40 bpm. Later, at 02:02:14 on (b)(6) 2020, the lifevest detected vt and ventricular fibrillation (vf) and delivered a second appropriate treatment. The patient's post-shock rhythm was sinus bradycardia at 50 bpm. Then at 03:06:13 and 03:06:38, the patient received two inappropriate treatments during asystole. Asystole is a non-treatable rhythm. Possible cpr/motion artifact and oversensing of low amplitude cardiac signal contributed to the false detection. The response buttons were not pressed during the event. The patient reportedly passed away on (b)(6) 2020 at approximately 3:45 am. There is no indication that a device malfunction caused or contributed to the patient's death. During the investigation of the patient's electrode belt following the event, a reportable malfunction was found.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008642652-2020-02710 |
| MDR Report Key | 9898532 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-02-15 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2015-09-07 |
| Date Added to Maude | 2020-03-30 |
| 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 | ELIZA SCHALLY |
| 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 | 2020-03-30 |
| Returned To Mfg | 2020-03-10 |
| Model Number | WCD 4000 |
| Catalog Number | 10A0988 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Death; 2. Other | 2020-03-30 |