MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION PROPAQ MD DEFIBRILLATOR; DEFIBRILLATOR/PACEMAKER

Model Number	PROPAQ MD
Medical Device Problem Code	Loss of Power (1475)
Health Effect - Clinical Code	No Information (3190)
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 restarted multiple times.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; the reported malfunction was observed during review of the device's activity log.The device was put through extensive troubleshooting without duplicating the reported malfunction.The device's monitor board and defib receptacle were replaced as a precaution.The device passed the final test procedure, was recertified, and returned to the customer.Analysis for reports of this type has not identified an increase in trend.

• Brand Name: PROPAQ MD DEFIBRILLATOR
• Common Device Name: DEFIBRILLATOR/PACEMAKER
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 6983503
• Report Number: 1220908-2017-02661
• Device Sequence Number: 11069562
• 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): 10/06/2017

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: 10/17/2017
• Initial Date Received by Manufacturer: 10/06/2017
• Supplement Date Received by Manufacturer: 10/06/2017
• Initial Report FDA Received Date: 10/27/2017
• Supplement Report FDA Received Date: 12/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1