MAUDE Adverse Event Report: ZOLL MANUFACTURING CORPORATION LIFEVEST WCD 4000 SYSTEM; WEARABLE CARDIOVERTER DEFIBRILLATOR

Model Number	WCD 4000
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	02/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Biocompatibility testing to iso 10993 was successfully completed on skin-contacting surfaces of the lifevest device as well as the blue(tm) defibrillation gel.
Event or Problem Description
A us distributor contacted zoll to report that a patient developed a skin irritation.The irritation was described as red, itchy, and under the electrodes and therapy pads.The patient described the irritation as hives.There are no allegations of any bleeding, oozing, or weeping wounds.It was reported the patient has known allergies.There was no alleged device malfunction contributing to the irritation.The patient used benadryl and unscented lotion on his own.The patient's doctor advised to remove the device.The irritation improved.
Event or Problem Description
A us distributor contacted zoll to report that a patient developed a skin irritation.The irritation was described as red, itchy, and under the electrodes and therapy pads.The patient described the irritation as hives.There are no allegations of any bleeding, oozing, or weeping wounds.It was reported the patient has known allergies.There was no alleged device malfunction contributing to the irritation.The patient used benadryl and unscented lotion on his own.The patient's doctor advised to remove the device.The irritation improved.Supplemental report 10/05/2021: submitting report to correct section g4.
Additional Manufacturer Narrative
Biocompatibility testing to iso 10993 was successfully completed on skin-contacting surfaces of the lifevest device as well as the blue(tm) defibrillation gel.
Event or Problem Description
A us distributor reported that a battery charger was resetting.
Additional Manufacturer Narrative
Device evaluation of battery charger/modem has been completed.The reported problem (charger resets) 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.
Additional Manufacturer Narrative
Device evaluation of battery charger/modem has been completed.The reported problem (charger resets) 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 resetting.

• Brand Name: LIFEVEST WCD 4000 SYSTEM
• 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: 11399469
• Report Number: 3008642652-2021-01911
• Device Sequence Number: 17030579
• 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: Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/15/2021

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: WCD 4000
• Device Catalogue Number: 10A0988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 02/24/2021; 02/18/2022; 02/18/2022
• Initial Report FDA Received Date: 03/02/2021
• Supplement Report FDA Received Date: 10/05/2021; 03/15/2022; 03/16/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown