MAUDE Adverse Event Report: WELCH ALLYN PROTOCOL, INC AED10; AUTOMATED EXTERNAL DEFIB

Model Number	AED10
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Information (3190)
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 (b)(6) male patient, the device was unable to resuscitate the patient.No further information was provided.
Additional Manufacturer Narrative
The complainant was contacted for return of the device.The device has not been returned to zoll for evaluation.

• Brand Name: AED10
• Common Device Name: AUTOMATED EXTERNAL DEFIB
• Manufacturer (Section D): WELCH ALLYN PROTOCOL, INC; 8500 sw creekside place; beaverton OR 97008 7107
• MDR Report Key: 8345646
• Report Number: 3023750-2019-00001
• Device Sequence Number: 2203074
• Product Code: MKJ
• UDI-Device Identifier: 00847946021689
• UDI-Public: 00847946021689
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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): 01/28/2019

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: AED10
• Device Catalogue Number: AED10
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/28/2019
• Supplement Date Received by Manufacturer: 01/28/2019
• Initial Report FDA Received Date: 02/15/2019
• Supplement Report FDA Received Date: 03/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 22 YR