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	04/06/2022
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 monitor a male patient (age unknown), the device displayed a "poor pad contact" message.Complainant indicated that the clinician obtained another device (sn: (b)(4)) to continue treating the patient and that device also displayed a "poor pad contact" message.The clinician obtained a non zoll device to continue treating the patient.Complainant indicated that the patient subsequently expired.
Additional Manufacturer Narrative
Zoll medical corporation received the device and the electrodes and the device performed to specification.The device was recertified and returned to the customer.The device was put through extensive testing including shock testing, ecg testing, bench handling, and an internal inspection using customer returned pads, multi-function cable, and ecg cables without duplicating any malfunction to the device.Review of both device logs (reference sr 904526) the users switch to manual defib mode and are prompted with a "check pads" and "poor pad contact" messages.The device is then turned off approximately 13 minutes later."check pad" and "poor pad contact" messages will be recorded in the log and prompt the user when the device recognizes that the measure patient impedance is out of range.This can be caused by several factors outside of a device malfunction including but not limited to poor patient coupling.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: 14251949
• Report Number: 1220908-2022-01501
• Device Sequence Number: 19917987
• Product Code: MKJ
• UDI-Device Identifier: 00847946020293
• UDI-Public: 00847946020293
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 04/08/2022

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2022
• 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: 04/08/2022
• Supplement Date Received by Manufacturer: 04/08/2022
• Initial Report FDA Received Date: 04/29/2022
• Supplement Report FDA Received Date: 07/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: R SERIES, (B)(6)
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Male