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

Model Number	MSERIES BI-PHASIC
Medical Device Problem Code	Failure to Capture (1081)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/23/2018
Type of Reportable Event	Malfunction
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 pace a male patient (age unknown), the device failed to capture the patient's heart rhythm.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.Please reference medwatch report 1220908-2018-02627 for a similar event reported on the same patient.
Additional Manufacturer Narrative
This supplemental medwatch report is reporting the evaluation of the device.This supplemental medwatch report is also correcting information submitted on the initial medwatch report.This investigation reflects both of the devices used during this patient event.The device's were returned to zoll medical corporation and the customer's report was not replicated or confirmed.The device's were put through extensive testing including bench handling, defib testing, ecg testing, stress teasing , impedance testing and pace testing on a simulator without duplicating the report.The device's were recertified and returned to the customer.The customer's multi-function cables and ecg cables were inspected with no faults found.The non-zoll electrode pads and adaptors involved were not returned as part of this investigation.No clinical data was available.No trend is associated with reports of this type.
Event or Problem Description
Complainant alleged that while attempting to pace a male patient (age unknown), the device failed to capture the patient's heart rhythm.Complainant indicated that the clinician obtained another device (sn-t03h49036) and the device failed to capture the patient's heart rhythm.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.Please reference medwatch report 1220908-2018-02627 that was inadvertently submitted for the second device used on this patient.

• Brand Name: M SERIES
• Common Device Name: DEFIBRILLATOR/PACEMAKER
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 7882597
• Report Number: 1220908-2018-02582
• Device Sequence Number: 11240149
• Product Code: MKJ
• UDI-Device Identifier: 00847946004613
• UDI-Public: 00847946004613
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K990762
• 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): 08/28/2018

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: MSERIES BI-PHASIC
• Device Catalogue Number: M SERIES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/28/2018
• Supplement Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 09/17/2018
• Supplement Report FDA Received Date: 10/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1