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

Model Number	MSERIES CCT
Medical Device Problem Code	Loss of Power (1475)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The malfunction was observed during initial testing; however after disassembling the device to determine root cause, the reported malfunction was no longer seen.The device was put through extensive testing without duplicating the reported malfunction.The battery interconnect board was replaced as a precaution.The device successfully passed the final test procedure, was recertified, and returned to the customer.Analysis for reports of this type has not identified an increase in trend.
Event or Problem Description
Complainant alleged that while attempting to treat a patient (age & gender unknown), the device inappropriately shut down.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.

• Brand Name: M SERIES
• Common Device Name: DEFIBRILLATOR/PACEMAKER
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 7406121
• Report Number: 1220908-2018-00996
• Device Sequence Number: 19145595
• Product Code: MKJ
• UDI-Device Identifier: 00847946004828
• UDI-Public: 00847946004828
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K011865
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/26/2018

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
• Operator of Device: Health Professional
• Device Model Number: MSERIES CCT
• Device Catalogue Number: M SERIES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2018
• Initial Report FDA Received Date: 04/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1