MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION PROPAQ MD DEFIBRILLATOR

Model Number	PROPAQ MD
Medical Device Problem Codes	Loss of Power (1475); Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that while attempting to monitor a (b)(6) male patient during flight transport, the device inappropriately shut down.Complainant indicated that the clinician reported they powered the device back on and monitored for several minutes before the device inappropriately shut down.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
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.Device evaluation: the device was returned to zoll medical corporation; the customer's report was observed during review of the device's history log.However, the reported problem could not be duplicated with the device.The multi-function connector was observed to have foreign debris inside the connector which may have contributed to the customer report, but this could not be confirmed.The multi-function connector and monitor board were replaced as a precaution.The device was recertified and returned to the customer.Analysis for reports of this type has not identified an increase in trend.
Event or Problem Description
Complainant alleged that while attempting to monitor a (b)6) year old male patient during flight transport, the device restart/reboot itself.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.

• 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: 7357521
• Report Number: 1220908-2018-00716
• Device Sequence Number: 11190214
• Product Code: MKJ
• UDI-Device Identifier: 00847946017729
• UDI-Public: 00847946017729
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K100654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2018

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
• Date Returned to Manufacturer: 03/26/2018
• Initial Date Received by Manufacturer: 03/02/2018
• Supplement Date Received by Manufacturer: 03/02/2018
• Initial Report FDA Received Date: 03/21/2018
• Supplement Report FDA Received Date: 04/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR