MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ZOLL X SERIES CARDIAC MONITOR; MONITOR, CARDIAC

Model Number X SERIES

Device Problem Unable to Obtain Readings (1516)

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

Event Date 08/01/2019

Event Type  malfunction  

Event Description

Dispatched for a pt not conscious and not breathing.Upon arrival cpr initiated and als initiated.While working on the pt the pt regained the ability to breathe and a pulse.An attempt was made to get a 12 lead ekg but there was no reading on lead v6.Multiple attempts were made to get the reading.All other leads read correctly.Upon arrival back in quarters, crews tried to replicate problem without success.Monitor has functioned fine since the incident.Fda safety report id# (b)(4).

• Brand Name: ZOLL X SERIES CARDIAC MONITOR
• Type of Device: MONITOR, CARDIAC
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION ; chelmsford MA 01824
• MDR Report Key: 8864837
• MDR Text Key: 153856832
• Report Number: MW5088772
• 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: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• 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 Outcome(s): Other
• Patient Age: 60 YR
• Patient Weight: 109