MAUDE Adverse Event Report: PHYSIO-CONTROL LIFEPAK AED INFANT/CHILD; AUTOMATED EXTERNAL DEFIBRILLATORS

Model Number	3202380-006
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Event or Problem Description
Received email notification that the infant/child aed lifepak was recalled.We would like it to be replaced.

• Brand Name: LIFEPAK AED INFANT/CHILD
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS
• Manufacturer (Section D): PHYSIO-CONTROL
• MDR Report Key: 7013616
• Report Number: MW5073202
• Device Sequence Number: 16653170
• Product Code: MKJ
• UDI-Device Identifier: 00721902629013
• UDI-Public: 00721902629013
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date (Section B): 11/06/2017

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?: No
• Operator of Device: No Information
• Device Expiration Date: 01/26/2019
• Device Model Number: 3202380-006
• Device Catalogue Number: 11101-000016
• Device Lot Number: 618923
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/09/2017
• Patient Sequence Number: 1