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

Model Number	R SERIES
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	Necrosis (1971)
Date of Event	04/09/2022
Type of Reportable Event	Death
Event or Problem Description
Complainant alleged that while attempting to defibrillate a patient (age & gender unknown), the device was unable to obtain an ecg signal 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
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
Additional Manufacturer Narrative
The device was not returned to zoll medical for evaluation.Instead, the device log files were provided for evaluation.Review of the logs could not confirm the customer's report.There is no evidence within the log that electrode pads were applied on the given event date.There were no check pads or poor pad contact messages recorded in the logs.The logs did show that the device was in lead ii, while in pacer mode and monitor mode.No indications were seen that the device was changed into defib mode by the user.However, without evaluation of the device, or the full disclosure logs, root cause could not be firmly established.Analysis of 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
• Manufacturer Contact: 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 14339890
• Report Number: 1220908-2022-01625
• Device Sequence Number: 5237105
• Product Code: MKJ
• UDI-Device Identifier: 00847946017569
• UDI-Public: 00847946017569
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P160022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2022

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2022
• Supplement Date Received by Manufacturer: 04/18/2022
• Initial Report FDA Received Date: 05/09/2022
• Supplement Report FDA Received Date: 07/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown