MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION PROPAQ MD DEFIBRILLATOR

Model Number	PROPAQ MD
Medical Device Problem Codes	Failure to Deliver Shock/Stimulation (1133); Energy Output Problem (1431)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
Event or Problem Description
Complainant alleged that while attempting to treat a patient (age & gender unknown), the device failed to discharge and internally dumped the energy after charging up to defibrillate the patient.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
Zoll medical corporation evaluated the device and multi-function cable.The device and cable performed to specification.The device was put through extensive testing including bench handling, power cycling, full functionality testing, button testing, shock button testing and defib cycle testing without duplicating the report.The device was recertified and returned to the customer.Review of the device activity logs showed multiple occurrences of charging events.However, during the charge events, the device was in a lead fault state and the energy was internally discharged.Until the fault state is corrected the device will not recognize a valid patient impedance and will not deliver energy.The logs did show one occurence were the lead fault was cleared and the device delivered a shock to the patient.The errors observed in the log could indicate poor coupling of the electrode pads to the patient's skin.However, the electrode pads were not returned as part of this investigation and this could not be firmly established.Analysis of reports of this type has not identified an increase in trend.

• 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: 9251080
• Report Number: 1220908-2019-03358
• Device Sequence Number: 2449010
• Product Code: MKJ
• UDI-Device Identifier: 00847946017651
• UDI-Public: 00847946017651
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K100654
• 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): 10/08/2019

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: PROPAQ MD
• Device Catalogue Number: PROPAQ MD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/08/2019
• Supplement Date Received by Manufacturer: 10/08/2019
• Initial Report FDA Received Date: 10/29/2019
• Supplement Report FDA Received Date: 11/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1