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

Model Number	MSERIES BI-PHASIC
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has received the device and will be providing a supplemental report when our investigation is completed.
Event or Problem Description
Complainant alleged that while attempting to cardiovert a patient (age & gender unknown) the device did not have ecg signal via attached electrode pads.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.
Additional Manufacturer Narrative
Zoll medical corporation evaluated the device and the reported malfunction was not replicated or confirmed.The device was put through extensive testing which included bench handling, full pads functionality testing with the returned multifunction cable and the test pads without duplicating the malfunction.The electrode pads used during the event were not available for evaluation.The device was recertified and returned to the customer.Investigation of the ecg leads view isolated an issue to the ecg connector.We suspect this is what the customer saw, but we cannot firmly establish.This would have not impacted the devices ability to deliver therapy.No trend is associated with reports of this type.

• Brand Name: M SERIES
• Common Device Name: DEFIBRILLATOR/PACEMAKER
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 8545551
• Report Number: 1220908-2019-01155
• Device Sequence Number: 13546527
• Product Code: DRT
• UDI-Device Identifier: 00847946002893
• UDI-Public: 00847946002893
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 04/03/2019

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: 04/10/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/03/2019
• Supplement Date Received by Manufacturer: 04/03/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 06/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1