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

Model Number 1000

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem No Patient Involvement (2645)

Event Date 09/11/2019

Event Type  malfunction  

Manufacturer Narrative

Physio-control evaluated the customer's device and verified the device had logged an event code into its memory.The customer was provided with a replacement device.Physio-control further evaluated the device and observed that the device was slow to charge and the delivered energy was lower than expected.The cause of the reported issue was determined to be due to a damaged component, designator u1, on the analog pcb assembly.

Event Description

The customer contacted physio-control to report that their device had logged an event code into its memory.Upon further evaluation, physio-control observed that the device was slow to charge and the delivered energy was lower than expected.In this state, wrong defibrillation therapy may be provided, if it were needed.There was no patient use associated with the reported event.

• Brand Name: LIFEPAK(R) 1000 DEFIBRILLATOR
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• Manufacturer (Section G): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• Manufacturer Contact: todd bandy ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 9672077
• MDR Text Key: 190778199
• Report Number: 0003015876-2020-00165
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K122600
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/05/2020

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
• Device Operator: Health Professional
• Device Model Number: 1000
• Device Catalogue Number: 99425-000199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2020
• Initial Date FDA Received: 02/05/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1