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

Model Number	X SERIES
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has received the device and will be providing a supplemental report when our investigation is completed.
Event or Problem Description
Complainant alleged that while attempting to treat an (b)(6) year old female patient, the device inappropriately shut down.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.Please reference medwatch report 1220908-2019-02220 for a similar event reported from the same customer.
Additional Manufacturer Narrative
Zoll medical corporation evaluated the device and the reported malfunction was not replicated or confirmed.The device was put through extensive troubleshooting which included stress testing on ac and battery without any discrepancies.The device was recertified and returned to the customer.No trend is associated with reports of this type.Review of the activity logs did not find evidence to support the reported event.

• Brand Name: X SERIES
• Common Device Name: DEFIBRILLATOR/PACEMAKER
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 8880620
• Report Number: 1220908-2019-02221
• Device Sequence Number: 18895611
• Product Code: MKJ
• UDI-Device Identifier: 00847946005917
• UDI-Public: 00847946005917
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K112432/P160
• 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): 07/19/2019

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: Other
• Device Model Number: X SERIES
• Device Catalogue Number: X SERIES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/19/2019
• Supplement Date Received by Manufacturer: 07/19/2019
• Initial Report FDA Received Date: 08/09/2019
• Supplement Report FDA Received Date: 09/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 87 YR