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

Model Number	X SERIES
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleged that during biomed testing, the device displayed a do not use icon.Complainant indicated that there was no patient involvement in the reported malfunction.
Additional Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
Additional Manufacturer Narrative
The device was returned to zoll medical corporation for evaluation.During the investigation the technician discovered that the customer attempted repair of the device.As a result of the device being tampered with, root cause could not be firmly established.The monitor board was replaced as a precaution.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
• Manufacturer Contact: 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 13096520
• Report Number: 1220908-2021-04437
• Device Sequence Number: 11893386
• Product Code: MKJ
• UDI-Device Identifier: 00847946020460
• UDI-Public: 00847946020460
• 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): 12/07/2021

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: 12/13/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/07/2021
• Supplement Date Received by Manufacturer: 12/07/2021
• Initial Report FDA Received Date: 12/28/2021
• Supplement Report FDA Received Date: 01/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown