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

Model Number	X SERIES
Medical Device Problem Code	Failure of Device to Self-Test (2937)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	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 shock and functional testing without duplicating the malfunction.No trend is associated with reports of this type.Review of device logs indicates that after the device's multifunction cable is shorted and the device is charged, the device enters into the rescue protocol.At this point the device dumps the energy internally.The log does not show any evidence of device malfunction.
Event or Problem Description
Complainant alleged that during a routine shift check by a clinician, the device failed self test.Complainant indicated that there was no patient involvement in the reported malfunction.

• Brand Name: X SERIES
• Common Device Name: DEFIBRILLATOR/PACEMAKER
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 8363460
• Report Number: 1220908-2019-00448
• Device Sequence Number: 19322468
• Product Code: MKJ
• UDI-Device Identifier: 00847946006389
• UDI-Public: 00847946006389
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K112432/P160
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/01/2019

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: Health Professional
• Device Model Number: X SERIES
• Device Catalogue Number: X SERIES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2019
• Initial Report FDA Received Date: 02/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1