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

Model Number	1000
Medical Device Problem Code	Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control evaluated the customer's device and was able to verify the reported issue.Physio determined that the cause of the reported issue was due to the analog pcb assembly.A therapy harness ferrite bead was placed over integrated circuit, designator u1, which broke the solder connections at legs 1 and 10 and caused excessive voltage on discharge which burned resistor, designator r212.
Event or Problem Description
The customer contacted physio-control to report that their device displayed the service indicator and was alarming.There was no patient use associated with the reported event.Upon evaluating the customer's device, physio observed a failure that resulted in a partial loss of defibrillator output energy due to a loss of the negative portion of the biphasic output waveform, resulting in a monophasic shock.As a result, the wrong defibrillation therapy would be delivered, if it were necessary.
Event or Problem Description
The customer contacted physio-control to report that their device displayed the service indicator and was alarming.There was no patient use associated with the reported event.Upon evaluating the customer's device, physio observed a failure that resulted in a partial loss of defibrillator output energy due to a loss of the negative portion of the biphasic output waveform, resulting in a monophasic shock.As a result, the wrong defibrillation therapy would be delivered, if it were necessary.
Additional Manufacturer Narrative
Section d4 of the initial medwatch report indicates: device identifier (di) number ¿ blank.Section d4 of the initial medwatch report should indicate: 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: 7390716
• Report Number: 0003015876-2018-00529
• Device Sequence Number: 785804
• 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: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 1000
• Device Catalogue Number: 99425-000023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2018
• Initial Date Received by Manufacturer: 03/09/2018
• Supplement Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 04/02/2018
• Supplement Report FDA Received Date: 02/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1