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

Model Number XSCP-1

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Date 11/02/2020

Event Type  malfunction  

Event Description

During cpr advanced airways was inserted in patient.Patient was on defib pads connected to monitor, and monitor had been turned on and reading patient cardiac rhythm for 4-5 minutes.Monitor had been turned on and functioning for a few minutes without any faults or issues being displayed on screen.After insertion of airway device, etco2 monitoring was attempted per protocol.After connecting etco2 adapter to monitor and pushing etco2 button on monitor the monitor states that there is an error with the etco2 monitoring and servicing is required.Was unable to use etco2 monitoring to monitor quality of cpr, airway placement, or patient condition throughout cpr event.The monitor was turned on and a test shock performed per protocol at the start of the shift and the monitor gave no indication that any of the functions of the monitor were not functioning properly.Monitor was turned in to ems chief, and is not available at this time to gather serial number.Though, if necessary to track down it has an asset number used by this ems agency.The asset number is 20423.Fda safety report id # (b)(4).

• Brand Name: ZOLL MEDICAL CORPORATION X SERIES
• Type of Device: MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; chelmsford MA 01824
• MDR Report Key: 10792679
• MDR Text Key: 215087996
• Report Number: MW5097666
• Device Sequence Number: 1
• Product Code: DRT
• 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: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: XSCP-1
• 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: 65 YR
• Patient Weight: 118