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

Model Number	R SERIES
Medical Device Problem Code	Failure to Deliver Shock/Stimulation (1133)
Health Effect - Clinical Code	Death (1802)
Type of Reportable Event	Death
Additional Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
Event or Problem Description
Complainant alleged that while attempting to defibrillate a patient (age & gender unknown), the device failed to discharge via electrode pads.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant indicated that the patient subsequently expired.
Additional Manufacturer Narrative
The device was returned to zoll medical corporation and the customer's report was not replicated or confirmed.The device was put through extensive testing without duplicating the report.The device made all the appropriate lead view changes and charged/shocked as expected, all buttons were tested for functionality and were found to be in working order.The device was recertified and returned to the customer.Review of teh device activity logs found that immediatley upon powering up, the device displayed "check pads/poor pad contact" messages.The energy down button was pressed dropping the energy to 30j, and the log recorded that the user pressed the charge button and then the analyze button.The device then recorded an analysis halt message.This will occur when the analyze button is pressed without a valid patient impedance.The shock button was then pressed, but no shock was delivered.The device would not be able to shock until it is able to identfy a valid patient impedance first.Which means that the check pads/poor pad contact message would need to be addressed by the user before the device could deliver the shock.The log further shows that throughout the day there are multiple successful shocks delivered indicating when all criteria is met the device is able to discharge.The electrode pads were not returned as part of this investigation.No trend is associated with reports of this type.

• 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: 10195219
• Report Number: 1220908-2020-01810
• Device Sequence Number: 19448281
• Product Code: MKJ
• UDI-Device Identifier: 00847946002442
• UDI-Public: 00847946002442
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 06/18/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/04/2020
• Supplement Date Received by Manufacturer: 06/04/2020
• Initial Report FDA Received Date: 06/25/2020
• Supplement Report FDA Received Date: 07/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death