MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION PROPAQ MD DEFIBRILLATOR

Model Number	PROPAQ MD
Medical Device Problem Codes	No Display/Image (1183); Failure to Power Up (1476)
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 would not power up.Complainant indicated that there was no patient involvement in the reported malfunction.
Additional Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Additional Manufacturer Narrative
This supplemental medwatch report is reporting the evaluation of the device.This supplemental medwatch report is also correcting information submitted on the initial medwatch report.Please reference section b5 and h6 (medical device problem code).Device evaluation: 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 front enclosure cable was not seated properly.The cable was reseated.The device was recertified and returned to the customer.The tamper proof label was found damaged which indicates that an unauthorized personnel attempted repair which is not recommended.Analysis for reports of this type has not identified an increase in trend.
Event or Problem Description
Complainant alleged that during biomed testing, the device powered on without display.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.

• Brand Name: PROPAQ MD DEFIBRILLATOR
• Common Device Name: PROPAQ MD
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• Manufacturer Contact: scott august ; 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 17023765
• Report Number: 1220908-2023-01926
• Device Sequence Number: 15171523
• Product Code: MKJ
• UDI-Device Identifier: 00847946020156
• UDI-Public: 00847946020156
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P160022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/09/2023

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2023
• Supplement Date Received by Manufacturer: 05/09/2023; 05/09/2023
• Initial Report FDA Received Date: 05/30/2023
• Supplement Report FDA Received Date: 06/23/2023; 08/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2018
• 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