MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION PROPAQ MD DEFIBRILLATOR

Model Number	PROPAQ MD
Medical Device Problem Codes	Failure to Deliver Shock/Stimulation (1133); Activation Problem (4042)
Health Effect - Clinical Code	No Patient Involvement (2645)
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 during biomed testing, the device displayed a "defibrillation not possible" message and the device did not respond to the front panel controls.Complainant indicated that there was no patient involvement in the reported malfunction.
Additional Manufacturer Narrative
The device was not returned to zoll medical for evaluation.Instead, data files from the event were provided for review.The customer's report was observed during review of the data files.However, all observations within the different logs could not be used to determine the cause of these issues.Without the device being evaluated, root cause 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: 9701234
• Report Number: 1220908-2020-00230
• Device Sequence Number: 2860952
• 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): 01/22/2020

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: 01/22/2020
• Supplement Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 03/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1