MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION X SERIES; DEFIBRILLATOR/PACEMAKER

Model Number X SERIES

Device Problem Unable to Obtain Readings (1516)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to zoll medical corporation and the customer's report was not replicated or confirmed.The device was put through extensive testing including bench handling, stress testing, full functionality testing and ecg testing without duplicating any malfunction to the device.The device was recertified and returned to the customer.Review of the device did show an ecg advisory condition.However, this type of notification can occur when the multi-function cable or receptacle is receiving a poor connection or coupling.This could not be firmly established as the multi-function cable used was not returned as part of this investigation.The log entries do not appear to be the result of a device malfunction.No trend is associated with reports of this type.

Event Description

Complainant alleged that while attempting to monitor a patient (age & gender unknown), the device displayed an "ecg disabled" message.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.

• Brand Name: X SERIES
• Type of Device: DEFIBRILLATOR/PACEMAKER
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• Manufacturer Contact: 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 9488635
• MDR Text Key: 171992796
• Report Number: 1220908-2019-03917
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 00847946004378
• UDI-Public: 00847946004378
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112432/P160
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: X SERIES
• Device Catalogue Number: X SERIES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1