MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION PROPAQ MD DEFIBRILLATOR

Model Number	PROPAQ MD
Medical Device Problem Code	Failure to Deliver Shock/Stimulation (1133)
Health Effect - Clinical Code	No Patient Involvement (2645)
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 during functional testing, the device failed to discharge.Complainant did not indicate that there was any patient involvement in the reported malfunction.
Additional Manufacturer Narrative
Zoll medical corporation evaluated the front enclosure and the reported malfunction was not replicated or confirmed.The front enclosure was placed on a test device and put through extensive testing without duplicating the malfunction.The front enclosure was scrapped.No trend is associated with reports of this type.

• 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: 8478588
• Report Number: 1220908-2019-00848
• Device Sequence Number: 19211365
• Product Code: MKJ
• UDI-Device Identifier: 00847946017705
• UDI-Public: 00847946017705
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K100654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2019

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?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/13/2019
• Supplement Date Received by Manufacturer: 03/13/2019
• Initial Report FDA Received Date: 04/03/2019
• Supplement Report FDA Received Date: 04/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1