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

Model Number	MSERIES BI-PHASIC
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
Event or Problem Description
Complainant alleged that during a routine shift check by a clinician, the device would not power up.Complainant indicated that there was no patient involvement in the reported malfunction.
Additional Manufacturer Narrative
The customer's report was observed during initial testing; however after disassembling the device to determine root cause, the report was no longer seen.The device was put through extensive testing without duplicating the report.The ac charger was replaced as a precaution.The device 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.

• Brand Name: M SERIES
• Common Device Name: DEFIBRILLATOR/PACEMAKER
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 9527377
• Report Number: 1220908-2019-03997
• Device Sequence Number: 2651034
• Product Code: MKJ
• UDI-Device Identifier: 00847946002893
• UDI-Public: 00847946002893
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K990762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2019

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: Other
• Device Model Number: MSERIES BI-PHASIC
• Device Catalogue Number: M SERIES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/06/2019
• Supplement Date Received by Manufacturer: 12/06/2019
• Initial Report FDA Received Date: 12/27/2019
• Supplement Report FDA Received Date: 02/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1