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

Model Number	HWD 1000
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation of battery charger/modem has been completed.The reported problem (will not power on) has been confirmed.Upon investigation the battery charger/modem was unable to recharge a battery.The cause for the failure was isolated to a shorted q1 current-controlling transistor on the bedside pca.The root cause for the shorted q1 transistor could not be positively identified.No adverse event resulted from the damaged charger.
Event or Problem Description
A us distributor reported that a battery charger was unable to charge a battery.

• Brand Name: HWD
• Common Device Name: WEARABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh PA 15238 3495
• Manufacturer (Section G): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh PA 15238 3495
• Manufacturer Contact: landyn blinn ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 14085832
• Report Number: 3008642652-2022-03793
• Device Sequence Number: 12084398
• Product Code: MVK
• UDI-Device Identifier: 00855778005173
• UDI-Public: 00855778005173
• 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): 04/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: HWD 1000
• Device Catalogue Number: 10A0997
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 04/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown