MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ZOLL DEFIBRILLATOR SUREPOWER II X SERIES; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number PROPAQ M/MD

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/04/2024

Event Type  Injury  

Event Description

Patient coding for prolonged time.Zoll monitor had been working as expected.Patient had been shocked multiple times prior to malfunction.During the code a nurse went to shock the patient and it charged like normal but would not fire.It put up an error code saying to hold the shock button to defib, however, holding it didn't work.It was backed out, recharged and tried again with the same result.After clearing it out again staff continued cpr and went to get new pads, during that time the defib put out a small shock with cpr in progress and no charging of the machine.Staff replaced the pads and the machine worked appropriately after and provide multiple shocks after.The patient had been coded for an hour and a half prior to malfunction.

• Brand Name: ZOLL DEFIBRILLATOR SUREPOWER II X SERIES
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION
• MDR Report Key: 18704018
• MDR Text Key: 335461610
• Report Number: MW5151560
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946018634
• UDI-Public: (01)00847946018634
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/07/2024

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
• Device Operator: Health Professional
• Device Model Number: PROPAQ M/MD
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/13/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 62 YR
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic
• Patient Race: White