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

Model Number	HWD 1000
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	05/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The monitor sn (b)(4) and electrode cable sn (b)(4) were returned and found to be fully functional.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 hwd, can be found at http://www.Accessdata.Fda.Gov/cdrh_docs/pdf/p010030b.Pdf.The hwd detection algorithm complies with iec 60601-2-4 performance requirements for sensitivity and specificity.
Event or Problem Description
The patient was inappropriately treated 1 time by the hospital wearable defibrillator (hwd).The patient's neurological status at the time of the event is unknown.Motion artifact contributed to the false detection.The response buttons were pressed after the treatment was delivered.The response buttons functioned appropriately.No injury was reported from the treatment.The patient was in the hospital at the time of the event.No deficiencies were alleged against the device.

• 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: 11986319
• Report Number: 3008642652-2021-05001
• Device Sequence Number: 19627858
• 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
• Report Date (Section B): 06/11/2021

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: HWD 1000
• Device Catalogue Number: 10A0995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 06/11/2021
• 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