MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ZOLL R-SERIES DEFIBRILLATORS; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Patient Problem Insufficient Information (4580)

Event Date 04/11/2024

Event Type  malfunction  

Event Description

Zoll defibrillator "on" knob will lock up or jam when the unit is positioned on its side or not stored in its typical horizontal position; 27 devices were tested and 22 of the devices were found to experience this issue.Facility is aware that this has been reported to zoll and that they are investigating.Reference reports: mw5154273, mw5154274, mw5154275, mw5154276, mw5154277, mw5154278, mw5154279, mw5154280, mw5154281, mw5154282, mw5154283, mw5154284, mw5154285, mw5154286, mw5154287, mw5154288, mw5154289, mw5154290, mw5154292, mw5154293, mw5154294.

• Brand Name: ZOLL R-SERIES DEFIBRILLATORS
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION
• MDR Report Key: 19182621
• MDR Text Key: 341263716
• Report Number: MW5154291
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/22/2024

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/24/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1