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 not received the product for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that during biomed testing, the device was unable to power on.Complainant indicated that there was no patient involvement in the reported malfunction.
Additional Manufacturer Narrative
The device was returned to zoll medical corporation.During evaluation of the device to determine root cause, the technician observed extensive damage.The observed damage is typically a result of the device being tampered with.Root cause could not be firmly established due to the observed damage.No trend is associated with reports of this type.

• Brand Name: M SERIES
• Common Device Name: DEFIBRILLATOR/PACEMAKER
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 6445829
• Report Number: 1220908-2017-00645
• Device Sequence Number: 10864298
• Product Code: MKJ
• UDI-Device Identifier: 00847946004644
• UDI-Public: 00847946004644
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 03/09/2017

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
• 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: 03/24/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/09/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/30/2017
• Supplement Report FDA Received Date: 04/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1