MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION PROPAQ MD DEFIBRILLATOR

Model Number	PROPAQ MD
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/01/2020
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 while attempting to transport a patient via helicopter (age & gender unknown), on the flight deck of the uss theodore roosevelt, the device inappropriately shut down.Complainant indicated that the clinician obtained a second device (serial number (b)(4) ) to continue treating the patient and the device also inappropriately shut down.A third device (serial number unknown) was obtained and the third device also inappropriately shut down.The complainant indicated that the ship then secured the sps-48 radar, upon securing the radar, the devices contiinued working properly.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
The complainant was contacted for return of the device.The customer has responded that the device is working as expected and will not be returning to zoll for evaluation.

• Brand Name: PROPAQ MD DEFIBRILLATOR
• Common Device Name: PROPAQ MD
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 10979554
• Report Number: 1220908-2020-03916
• Device Sequence Number: 10960187
• Product Code: MKJ
• UDI-Device Identifier: 00847946017682
• UDI-Public: 00847946017682
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K100654
• 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): 11/18/2020

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: PROPAQ MD
• Device Catalogue Number: PROPAQ MD
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 11/18/2020
• Initial Report FDA Received Date: 12/09/2020
• Supplement Report FDA Received Date: 01/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1