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

Model Number X-SERIES

Device Problem Failure to Sense (1559)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/21/2019

Event Type  malfunction  

Event Description

Cardiac monitor would not detect the pt's heartbeat.While the pt had a palpable pulse in the range of the 70s.The cardiac monitor indicated a heart rate in the teens to twenties.This was verified in settings, the zoll was acquiring the heart rate via ecg.Palpable pulse and secondary sp02 monitor also verified pts heart rate in the 70s.Fda safety report id# (b)(4).

• Brand Name: ZOLL CARDIAC MONITOR
• Type of Device: MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION ; chelmford MA 01824
• MDR Report Key: 9384058
• MDR Text Key: 168454514
• Report Number: MW5091333
• 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: 11/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: X-SERIES
• Was Device Available for Evaluation?: Yes
• 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 Age: 69 YR
• Patient Weight: 113