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

Model Number X SERIES

Device Problem Failure to Read Input Signal (1581)

Patient Problem Ventricular Tachycardia (2132)

Event Type  malfunction  

Manufacturer Narrative

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 treat a patient (age & gender unknown), the device would not go into sync mode.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 device performed to specification.Review of the device activity logs indicate sync markers were detected in pads mode when the criteria was met.Further review of the activity logs also indicated that the device was never switched from pads view to a different ecg lead during the event.The device was put through extensive testing which included functional testing and it met zoll's specifications.Based on the evidence presented in the clinical file, the investigation is being closed as the device met specification.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: 7736354
• MDR Text Key: 115647593
• Report Number: 1220908-2018-02138
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946004354
• UDI-Public: 00847946004354
• 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
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/10/2018

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: 07/27/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/10/2018
• Initial Date FDA Received: 07/31/2018
• Supplement Dates Manufacturer Received: 07/10/2018
• Supplement Dates FDA Received: 08/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2016
• 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