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.
[185561024]
Device evaluation of electrode belt sn (b)(4) has been completed. Upon investigation the electrode belt failed an ecg fall-off test. The cable connecting ecg "a" and ecg "b" was pulled from the strain relief, damaging the j703 connector on the distribution node pca. There is no indication that the damaged electrode belt caused or contributed to the patient's passing. The root cause for the strained cable and damaged connector was excessive force. Device evaluation of monitor sn (b)(4) has been completed. During the incoming functional testing, a 1hz simulated normal sinus rhythm signal was applied to the monitor, 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 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 - 07111019 - 04/13/2015, belt - 59054094 - 04/19/2013.
Patient Sequence No: 1, Text Type: N, H10
[185561025]
A us distributor contacted zoll to report that a patient passed away on (b)(6) 2020. Review of the patient's download data reveals that the patient experienced a defibrillation event consisting of two shocks on (b)(6) 2020, the date of their passing. At 07:22:00 on (b)(6) 2020, the patient received an inappropriate treatment from the lifevest. The patient's rhythm at the time of the treatment delivery was supraventricular tachycardia (svt) with motion artifact and the patient's post-shock rhythm was induced ventricular tachycardia (vt) at 200 bpm. Svt contributed to the false detection. At 07:22:25, the patient received an appropriate treatment from the lifevest. The patient's rhythm at the time of the treatment was vt at 180 bpm. The patient's post-shock rhythm was sinus rhythm at 80 bpm. Per clinical review of the patient's continuous ecg data, the patient was in sinus tachycardia at 120 bpm slowing to an idioventricular rhythm at 30 bpm degrading to asystole with cpr/motion artifact and electrode lead falloff from approximately 08:22:58 until the device shutdown at 10:44:00 on (b)(6) 2020. Asystole is a non-treatable rhythm. The response buttons were not pressed during the event. Supraventricular tachycardia (svt) contributed to the false detection. The rapid rate satisfied the rate detector of the detection algorithm. The patient subsequently passed away in the hospital. There is no indication that a device malfunction caused or contributed to the patient's passing. During the investigation of the patient's electrode belt, a reportable malfunction was found.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008642652-2020-02711 |
| MDR Report Key | 9898535 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-02-25 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2013-04-19 |
| 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 | 2020-03-03 |
| 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 |