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.
[185569801]
Device evaluation of monitor sn (b)(4) and electrode belt sn (b)(4) has been completed. During the incoming functional testing, a 1hz simulated normal sinus rhythm signal was applied to the ecg electrodes, followed by a 5hz simulated treatable arrhythmia signal which verified proper performance of the detection algorithm. During the transition to the 5hz signal, the device was confirmed to properly enter into a treatment sequence which includes a verification of the tactile vibration alarm, audio messaging, and siren alarms, as well as a test of the pulse delivery circuitry. The pulse delivery circuitry test verified proper charging of the high voltage capacitors and proper delivery of five full energy 150j biphasic pulses. The functional testing confirmed proper response button functionality, ecg acquisition, detection algorithm performance, and pulse delivery functionality. There is no indication of a product malfunction. Manufacture date: monitor - (b)(4) - 02/07/2012, belt - (b)(4) - 01/17/2013.
Patient Sequence No: 1, Text Type: N, H10
[185569802]
A us distributor contacted zoll to report that a patient passed away on (b)(6) 2019. Review of the patient's download data reveals that the patient experienced an inappropriate defibrillation event consisting of three shocks on the day of their passing. It was reported that the patient was unconscious at the time of the treatment delivery. The response buttons were not pressed during the event. Oversensing of low-amplitude cardiac signal contributed to the false detection the patient subsequently passed away. Clinical review of the patients ecg data shows that the patient was in asystole during the entire treatment event. Asystole is a non-treatable rhythm. There is no indication that the lifevest caused or contributed to the patient's death.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008642652-2020-02709 |
| MDR Report Key | 9898533 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2019-12-08 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2012-02-07 |
| 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 | 2020-03-02 |
| 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 |