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

Model Number	R SERIES
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has received the device and will be providing a supplemental report when our investigation is completed.
Event or Problem Description
Complainant alleged that while attempting to treat a patient (age & gender unknown) in cardiac arrest, the device inappropriately shut down.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
The device was returned to zoll medical corporation; the malfunction was observed during review of the device's history log.The device was put through extensive testing which included bench handling and power cycling without duplicating the malfunction.The customer's battery was tested and it passed.However, it could not be confirmed if the battery returned by the customer was the same battery used at the time of reported event.The review of device's history logs confirms battery id fault which may have caused the customer report but we are unable to firmly establish cause.The battery interconnect board was replaced as a precaution.The device was recertified and returned to the customer.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: 8126422
• Report Number: 1220908-2018-03506
• Device Sequence Number: 1616177
• Product Code: MKJ
• UDI-Device Identifier: 00847946002572
• UDI-Public: 00847946002572
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,Followup
• Report Date (Section B): 11/12/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2018
• Supplement Date Received by Manufacturer: 11/12/2018
• Initial Report FDA Received Date: 12/03/2018
• Supplement Report FDA Received Date: 12/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1