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

Model Number	X SERIES
Medical Device Problem Code	Reset Problem (3019)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that during biomed testing, the device would reboot/restart itself.Complainant indicated that there was no patient involvement in the reported malfunction.
Additional Manufacturer Narrative
The complainant was contacted for return of the device.The device has not been returned to zoll for evaluation.
Additional Manufacturer Narrative
The device was returned to zoll approved service provider and the customer's report was not replicated or confirmed.The device was put through extensive testing including full system level testing without duplicating the report.An internal inspection found no discrepancies.The main board was replaced as a precaution.The device was recertified and returned to the customer.The device logs were not available as part of this investigation.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: 9728254
• Report Number: 1220908-2020-00359
• Device Sequence Number: 2513062
• Product Code: MKJ
• UDI-Device Identifier: 00847946005917
• UDI-Public: 00847946005917
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K112432/P160
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/29/2020

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: X SERIES
• Device Catalogue Number: X SERIES
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/29/2020
• Supplement Date Received by Manufacturer: 01/29/2020; 01/29/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 03/24/2020; 05/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1