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

Model Number	MSERIES BI-PHASIC
Medical Device Problem Code	Grounding Malfunction (1271)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The malfunction was duplicated and the ac receptacle was replaced to resolve the malfunction.Analysis of reports of this type has not identified an increase in trend.
Event or Problem Description
Complainant alleged that during biomed testing, the device failed ground resistance testing.Complainant indicated that there was no patient involvement in 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: 6463509
• Report Number: 1220908-2017-00734
• Device Sequence Number: 580466
• Product Code: MKJ
• UDI-Device Identifier: 00847946003944
• UDI-Public: 00847946003944
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Report Date (Section B): 03/17/2017

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): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2017
• Initial Report FDA Received Date: 04/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1