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

Model Number	X SERIES
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	Insufficient Information (4580)
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 during biomed testing,the device was unable to obtain an ecg signal via pads.Complainant did not indicate that there was any patient involvement in the reported malfunction.
Additional Manufacturer Narrative
Zoll medical corporation evaluated the device and the customer's report was not replicated or confirmed.The device was put through extensive testing using a test multifunction cable and 12 lead ecg cable by bench handling, ecg monitoring stress testing, and defib cycle testing without duplicating the report.The device was recertified and returned to the customer with a replacement multifunction cable and 12 lead ecg cable as a pre-caution.The cables used at the time of the reported event were not returned with the device for evaluation.No trend is associated with reports of this type.

• Brand Name: X SERIES
• Common Device Name: DEFIBRILLATOR/PACEMAKER
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 11711674
• Report Number: 1220908-2021-01199
• Device Sequence Number: 3908787
• Product Code: MKJ
• UDI-Device Identifier: 00847946018580
• UDI-Public: 00847946018580
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K112432/P160
• 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): 04/01/2021

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: X SERIES
• Device Catalogue Number: X SERIES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/01/2021
• Supplement Date Received by Manufacturer: 04/01/2021
• Initial Report FDA Received Date: 04/22/2021
• Supplement Report FDA Received Date: 05/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1