MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ZOLL PACEMAKER MONITOR; PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)

Device Problems Failure to Capture (1081); No Pacing (3268)

Patient Problem Insufficient Information (4580)

Event Date 06/03/2021

Event Type  Injury  

Event Description

The pacemaker portion of the zoll monitor showed pacer spikes but no rhythm or capture.Unable to pace patient.Troubleshooting occurred still was not working.Device replaced with another pediatric zoll that then paced patient and provided pacer capture.Patient lived while at our facility.Fda safety report id# (b)(4).

• Brand Name: ZOLL PACEMAKER MONITOR
• Type of Device: PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION
• MDR Report Key: 11999139
• MDR Text Key: 256533691
• Report Number: MW5101890
• Device Sequence Number: 1
• Product Code: DRO
• 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: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Date Returned to Manufacturer: 06/11/2021
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 106