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

Model Number	R SERIES
Medical Device Problem Codes	Grounding Malfunction (1271); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to zoll medical corporation.The malfunction of failed leakage testing was observed during initial testing; however after disassembling the device to determine root cause, the malfunction was no longer seen.The device was put through extensive testing without duplicating the malfunction.The analog board shields were replaced as a precaution.The reported malfunction of the device shuts down was not replicated or confirmed.The device was put through extensive testing which included bench handling, power cycling, functional stress testing, and hipot/leakage testing without duplicating the malfunction.Review of the clinical and error logs did not find evidence to support the reported event.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.
Event or Problem Description
Complainant alleged that during biomed testing, the device failed leakage current test and inappropriately shut down.Complainant indicated that there was no patient involvement in the reported malfunction.

• 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: 8734703
• Report Number: 1220908-2019-01687
• Device Sequence Number: 2271244
• Product Code: MKJ
• UDI-Device Identifier: 00847946002602
• UDI-Public: 00847946002602
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K060559/P160
• 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): 06/05/2019

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: R SERIES
• Device Catalogue Number: R SERIES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2019
• Initial Report FDA Received Date: 06/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1