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

Model Number	R SERIES
Medical Device Problem Codes	Grounding Malfunction (1271); Energy Output Problem (1431)
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 failed the earth ground resistance test and defib output was out of specification.Complainant indicated that there was no patient involvement in the reported malfunction.
Additional Manufacturer Narrative
The device was returned to zoll medical (b)(4); the malfunction for defib output incorrect was verified.The device's pace/defib engine assembly was replaced to remedy the problem.The reported malfunction for earth ground resistance test failed was not replicated or confirmed.The device was put through extensive testing without duplicating the malfunction.Analysis for reports of this type has not identified an increase in trend.
Additional Manufacturer Narrative
The device was not returned to zoll medical corporation; the device's pace/defib engine assembly was removed and returned.The malfunction was duplicated and attributed to a faulty capacitor on the pace/defib engine assembly.Analysis for reports of this type has not identified an increase in trend.

• Brand Name: R SERIES DEFIBRILLATOR
• Common Device Name: DEFIBRILLATOR/PACEMAKER
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 7264229
• Report Number: 1220908-2018-00362
• Device Sequence Number: 1475774
• Product Code: MKJ
• UDI-Device Identifier: 00847946002459
• UDI-Public: 00847946002459
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K060559
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/24/2018

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: Other
• Device Model Number: R SERIES
• Device Catalogue Number: R SERIES
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/24/2018
• Supplement Date Received by Manufacturer: 01/24/2018; 01/24/2018
• Initial Report FDA Received Date: 02/12/2018
• Supplement Report FDA Received Date: 03/16/2018; 05/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1