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

Model Number	AED PLUS
Medical Device Problem Code	Failure to Power Up (1476)
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 would not power up.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.The device was recertified and returned to the customer.Review of the device logs did show evidence of a battery issue.However, without evaluation of the battery from the event, a malfunction cannot be confirmed.No trend is associated with reports of this type.

• Brand Name: AED PLUS
• Common Device Name: DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 8527989
• Report Number: 1220908-2019-01059
• Device Sequence Number: 2384359
• Product Code: MKJ
• UDI-Device Identifier: 00847946099381
• UDI-Public: 00847946099381
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K011541/P160
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2019

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: AED PLUS
• Device Catalogue Number: AED PLUS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2019
• Supplement Date Received by Manufacturer: 03/28/2019
• Initial Report FDA Received Date: 04/18/2019
• Supplement Report FDA Received Date: 05/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1