MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION PROPAQ MD DEFIBRILLATOR

Model Number	PROPAQ MD
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 while attempting to treat a patient (age & gender unknown), the device powered on without display.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
The device was returned to zoll medical corporation for evaluation.The customer stated the device was dropped and this type of incident is consistent with damage used outside of the device's specification.The lcd display module was replaced to remedy the report.The device was recertified and returned to the customer.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: 10207349
• Report Number: 1220908-2020-01920
• Device Sequence Number: 14113673
• Product Code: MKJ
• UDI-Device Identifier: 00847946017644
• UDI-Public: 00847946017644
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 06/09/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2020
• Supplement Date Received by Manufacturer: 06/09/2020
• Initial Report FDA Received Date: 06/29/2020
• Supplement Report FDA Received Date: 08/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1