MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-29 for LIFEVEST WCD 4000 SYSTEM 10A0988 manufactured by Zoll Manufacturing Corporation.
[186205370]
There was no death or device malfunction associated with the inappropriate defibrillation event. Device evaluation summary: monitor sn (b)(4) and electrode belt sn (b)(4) were returned and evaluated at the distributor, in accordance with procedures recommended by zoll manufacturing corporation. The evaluation included review of downloaded software flag files on the day of the event and incoming functional testing. 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 inappropriate treatment. 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 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. Manufacture date: monitor - (b)(4) - 01/22/2014, belt - (b)(4) - 11/06/2015. The investigation into the event concludes that there was no device malfunction. A cause and effect analysis was conducted using all of the available information which includes the incident report, device evaluation, software flag files, and ecg strips. The primary cause of the inappropriate shock was lack of response button use by the patient during the false detection. The ecg analysis, conducted by trained ecg technicians, identified the primary cause of the false detection was atrial fibrillation (af) with rapid ventricular response (rvr). The rapid rate satisfied the rate detector of the detection algorithm. Inappropriate defibrillations are an anticipated risk associated with the use of the lifevest. Patients are instructed through alarms, voice messages, ifu, and training to press the response buttons to prevent an inappropriate defibrillation. The current commercial inappropriate defibrillation rate is consistent with the observed rate during the pivotal clinical trial (b)(4) (0. 69% per patient-month with 90% confidence). 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. The lifevest detection algorithm complies with iec 60601-2-4 performance requirements for sensitivity and specificity.
Patient Sequence No: 1, Text Type: N, H10
[186205371]
A us distributor contacted zoll to report that a patient experienced an inappropriate defibrillation event consisting of one shock. The response buttons were not pressed during the event. Atrial fibrillation (af) with rapid ventricular response (rvr) contributed to the false detection. The rapid rate satisfied the rate detector of the detection algorithm. The patient reportedly did not seek medical attention. There was no death or device malfunction associated with the inappropriate defibrillation event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008642652-2020-02697 |
| MDR Report Key | 9896089 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-03-29 |
| Date of Report | 2020-03-29 |
| Date of Event | 2019-12-23 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2018-02-21 |
| Date Added to Maude | 2020-03-29 |
| 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 | 2020-03-29 |
| Model Number | WCD 4000 |
| Catalog Number | 10A0988 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| 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. Other | 2020-03-29 |