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

Model Number	R SERIES
Medical Device Problem Codes	Unable to Obtain Readings (1516); Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that while attempting to cardiovert a patient (age & gender unknown), the device self discharged.Complainant indicated that the patient's rhythm did not change and the device prompted an unknown "ecg fault".Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
This supplemental medwatch report is reporting the evaluation of the device.This supplemental medwatch report is also updating information submitted on the initial medwatch report.Please reference section device code.Evaluation results: the reported malfunction of "device self discharged" was not duplicated during testing.Review of the device logs did not show any discharges during the reported event.The reported malfunction of "ecg fault 5 and ecg disabled" messages was attributed to a burnt resistor on the analog board.The device was recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.
Event or Problem Description
Complainant alleged that while attempting to cardiovert a patient (age & gender unknown), the device self discharged.Complainant indicated that the patient's rhythm did not changed and the device prompted "ecg fault 5" and "ecg disabled" messages.Complainant did not indicate that there was any adverse effect to the patient due to 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: 8128250
• Report Number: 1220908-2018-03496
• Device Sequence Number: 252035
• Product Code: MKJ
• UDI-Device Identifier: 00847946017545
• UDI-Public: 00847946017545
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 11/13/2018

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: 12/11/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/13/2018
• Supplement Date Received by Manufacturer: 11/13/2018
• Initial Report FDA Received Date: 12/04/2018
• Supplement Report FDA Received Date: 01/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1