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 Information (3190)
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 treat a patient (age & gender unknown), the device displayed a "defib pad short" message.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
The device and therapy cable were returned to zoll medical corporation and the customer's report was not replicated or confirmed.The device was put through extensive testing including bench handling, defib testing and ecg testing without duplicating a malfunction to the device.The device was recertified and returned to the customer.Further clarification obtained from the customer during our evaluation indicated that the user was using non zoll electrode pads.The non zoll pads were not returned as part of the investigation.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: 9752207
• Report Number: 1220908-2020-00441
• Device Sequence Number: 14004566
• Product Code: MKJ
• UDI-Device Identifier: 00847946003609
• UDI-Public: 00847946003609
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 02/04/2020

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: 02/11/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/04/2020
• Supplement Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 02/25/2020
• Supplement Report FDA Received Date: 03/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1