MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 1000 DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	1000
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control provided the customer, a biomedical engineer with technical assistance.The biomedical engineer evaluated the device and was unable to duplicate or verify the reported issue.After observing proper device operation through functional and performance testing, the device was returned for use.The device was not returned to physio-control for an evaluation.The cause of the reported issue could not be determined.Device not evaluated by manufacturer.
Event or Problem Description
The customer contacted physio-control to report that their device did not shock when they attempted to shock while using it on a patient.The customer was using infant/child reduced energy electrodes.The customer switched the infant/child electrodes with standard electrodes and were able to shock the patient using the standard electrodes.There were no reports of adverse effects to the patient as a result of the reported issue.Physio-control contacted the customer in order to obtain additional information about both the patient; however, the customer advised that no further details are available.
Event or Problem Description
The customer contacted physio-control to report that their device did not shock when they attempted to shock while using it on a patient.The customer was using infant/child reduced energy electrodes.The customer switched the infant/child electrodes with standard electrodes and were able to shock the patient using the standard electrodes.There were no reports of adverse effects to the patient as a result of the reported issue.Physio-control contacted the customer in order to obtain additional information about both the patient; however, the customer advised that no further details are available.
Additional Manufacturer Narrative
The initial medwatch report should indicate: gtin/device identifier (di) number ¿ (b)(4).

• Brand Name: LIFEPAK® 1000 DEFIBRILLATOR
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• MDR Report Key: 7452995
• Report Number: 0003015876-2018-00643
• Device Sequence Number: 10791396
• Product Code: MKJ
• UDI-Device Identifier: 00885074698878
• UDI-Public: 00885074698878
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K122600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2020

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: Lay User/Patient
• Device Model Number: 1000
• Device Catalogue Number: 99425-000023
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/29/2018
• Supplement Date Received by Manufacturer: 02/21/2020
• Initial Report FDA Received Date: 04/23/2018
• Supplement Report FDA Received Date: 02/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1