MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ZOLL X SERIES CARDIAC MONITOR; MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/20/2024

Event Type  malfunction  

Event Description

The blood pressure monitor read out of service needs repair when turned on at (b)(6) er for transport.Unable to process the blood pressure.The monitor check at time of truck check off had preformed without a issue.Blood pressures taken manually for the transport time and after the transport the monitor was checked and nothing found.The battery was removed and put back in place, this appeared to have fixed the issue and the monitor was left in service.The oncoming crew briefed on the situation and advised that all report and forms have been filed.

• Brand Name: ZOLL X SERIES CARDIAC MONITOR
• Type of Device: MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION
• MDR Report Key: 18623356
• MDR Text Key: 334439758
• Report Number: MW5150964
• Device Sequence Number: 1
• Product Code: DRT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• 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
• Patient Sequence Number: 1
• Patient Age: 90 YR
• Patient Sex: Female
• Patient Weight: 52 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White