MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION AED PRO; DEFIBRILLATOR

Model Number	AED PRO
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation evaluated the device and the reported malfunction was not replicated or confirmed.The device was put through extensive testing without duplicating the malfunction.Review of the clinical data confirmed 3 discharges using a simulator.It is noteworthy to mention the returned electrode pads were evaluated and it was determined the black mark on the apex conductor was from defibrillation.However there was no evidence it was the result of self-discharge.The device was recertified and returned to the customer.No trend is associated with reports of this type.
Event or Problem Description
Complainant alleged that during biomed testing, the device self discharged.Complainant indicated that there was no patient involvement in the reported malfunction.
Additional Manufacturer Narrative
Zoll medical corporation evaluated the device and the reported malfunction was not replicated or confirmed.The device was put through extensive testing without duplicating the malfunction.Review of the clinical data confirmed 3 discharges using a simulator.It is noteworthy to mention the returned electrode pads were evaluated and it was determined the black mark on the apex conductor was from defibrillation.However there was no evidence it was the result of self-discharge.The device was recertified and returned to the customer.No trend is associated with reports of this type.

• Brand Name: AED PRO
• Common Device Name: DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 6600591
• Report Number: 1220908-2017-01215
• Device Sequence Number: 10957779
• Product Code: MKJ
• UDI-Device Identifier: 00847946099329
• UDI-Public: 00847946099329
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K110526
• 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): 05/10/2017

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: AED PRO
• Device Catalogue Number: AED PRO
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2017
• Initial Date Received by Manufacturer: 05/10/2017
• Supplement Date Received by Manufacturer: 05/10/2017
• Initial Report FDA Received Date: 05/31/2017
• Supplement Report FDA Received Date: 08/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1