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

Model Number X SERIES

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.

Event Description

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

Manufacturer Narrative

Zoll medical corporation evaluated the device and the reported malfunction was not replicated or confirmed.The device was put through extensive testing without duplicating the malfunction.Review of the device history log provided evidence of the customer's report.The device's processor/bridge/pace board was replaced as a precaution.The device was recertified and returned to the customer.No trend is associated with reports of this type.

• 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: 7156238
• MDR Text Key: 96113532
• Report Number: 1220908-2017-03336
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946004378
• UDI-Public: 00847946004378
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112432
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: X SERIES
• Device Catalogue Number: X SERIES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/12/2017
• Initial Date FDA Received: 12/30/2017
• Supplement Dates Manufacturer Received: 12/12/2017
• Supplement Dates FDA Received: 01/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2016
• 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