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

Model Number	R SERIES
Medical Device Problem Codes	Failure to Deliver Shock/Stimulation (1133); Use of Device Problem (1670)
Health Effect - Clinical Code	Death (1802)
Date of Event	07/23/2019
Type of Reportable Event	Death
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 treat a patient (age & gender unknown), the device would not function.No further information was available.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant indicated that the patient subsequently expired.
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 event section and device code.Evaluation results: the device was not returned to zoll medical corporation for evaluation.Instead, the customer provided the incident log and full disclosure log from the reported event.Review of the incident logs showed that the device was successfully charged 4 times during the event.The first charge was held for 60 seconds before the energy was internally discharged.The logs available for review are not able to indicate if the users were attempting to shock during this time.The rest of the charges all resulted in successful shocks to the patient.The subsequent shocks indicate that the device was capable of providing therapy during this event.Analysis of reports of this type has not identified an increase in trend.
Event or Problem Description
Complainant alleged that while attempting to treat a patient (age & gender unknown), the device was unable to discharge.Complainant indicated that the clinician obtained another device to continue treating the patient.

• 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: 8889163
• Report Number: 1220908-2019-02261
• Device Sequence Number: 10821345
• Product Code: MKJ
• UDI-Device Identifier: 00847946002374
• UDI-Public: 00847946002374
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 07/23/2019

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?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/23/2019
• Supplement Date Received by Manufacturer: 07/23/2019
• Initial Report FDA Received Date: 08/13/2019
• Supplement Report FDA Received Date: 10/07/2019
• 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