MAUDE Adverse Event Report: ZOLL MANUFACTURING CORPORATION HOSPITAL WEARABLE DEFIBRILLATOR (HWD); WEARABLE CARDIOVERTER DEFIBRILLATOR

Model Number	WCD 4000
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	07/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The monitor sn (b)(4) and electrode belt sn (b)(4) have not been returned for evaluation.Based on the data available at this time, there is no indication of a device malfunction causing or contributing to the inappropriate treatment.Inappropriate defibrillations are an anticipated risk associated with the use of the hospital wearable defibrillator.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 and hwd, can be found at (http://www.Accessdata.Fda.Gov/cdrh_docs/pdf/p010030b.Pdf).The zoll detection algorithm complies with iec 60601-2-4 performance requirements for sensitivity and specificity.
Event or Problem Description
The patient was inappropriately treated three times.The patient's neurological status at the time of the event is unknown.Interference and artifact contributed to the false detection.The response buttons were not pressed during the event.No injury was reported from the treatment.No deficiencies were alleged against the device.
Event or Problem Description
Supplemental report 9/9/2021: this report was submitted in error.The treatment events occurred as part of a demonstration of the device and not while the device was being worn by a patient.The patient was inappropriately treated three times.The patient's neurological status at the time of the event is unknown.Interference and artifact contributed to the false detection.The response buttons were not pressed during the event.No injury was reported from the treatment.No deficiencies were alleged against the device.
Additional Manufacturer Narrative
The monitor sn (b)(6) and electrode belt sn (b)(6) have not been returned for evaluation.Based on the data available at this time, there is no indication of a device malfunction causing or contributing to the inappropriate treatment.Inappropriate defibrillations are an anticipated risk associated with the use of the hospital wearable defibrillator.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 and hwd, can be found at (http://www.Accessdata.Fda.Gov/cdrh_docs/pdf/p010030b.Pdf).The zoll detection algorithm complies with iec 60601-2-4 performance requirements for sensitivity and specificity.

• Brand Name: HOSPITAL WEARABLE DEFIBRILLATOR (HWD)
• Common Device Name: WEARABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh PA 15238 3495
• MDR Report Key: 12443474
• Report Number: 3008642652-2021-07771
• Device Sequence Number: 17008759
• Product Code: MVK
• UDI-Device Identifier: 00855778005159
• UDI-Public: 00855778005159
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P010030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: WCD 4000
• Device Catalogue Number: 10A0995
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2021
• Supplement Date Received by Manufacturer: 08/09/2021
• Initial Report FDA Received Date: 09/08/2021
• Supplement Report FDA Received Date: 09/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other