MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 20 DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS NON-WEARABLE

Model Number	20
Medical Device Problem Code	Failure to Deliver Shock/Stimulation (1133)
Health Effect - Clinical Codes	Cardiac Arrest (1762); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Physio-control continues to investigate the reported failure and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.
Event or Problem Description
Physio-control received a report from a customer of alleged device malfunction, "during a code call, the lp20 [lifepak® 20 defibrillator/monitor] failed to deliver a shock.The staff initially had philips pads on the unit, upon discovery they went and changed the pads out and hooked up stryker brand pads to the unit.When going to give a shock the unit failed to deliver one." the philips pads used are not approved for use with this defibrillator/monitor.This issue is patient related; however there was no adverse event reported.The customer swapped out the unit for another monitor/defibrillator and successfully delivered a shock.
Additional Manufacturer Narrative
Stryker found that the device was manufactured in 2005 and is beyond its expected service life of 8 years per the product manual.The customer was informed the device should be replaced and scrapped.
Event or Problem Description
Physio-control received a report from a customer of alleged device malfunction, "during a code call, the lp20 [lifepak® 20 defibrillator/monitor] failed to deliver a shock.The staff initially had philips pads on the unit, upon discovery they went and changed the pads out and hooked up stryker brand pads to the unit.When going to give a shock the unit failed to deliver one." the philips pads used are not approved for use with this defibrillator/monitor.This issue is patient related; however there was no adverse event reported.The customer swapped out the unit for another monitor/defibrillator and successfully delivered a shock.

• Brand Name: LIFEPAK® 20 DEFIBRILLATOR/MONITOR
• Common Device Name: 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: 12586248
• Report Number: 0003015876-2021-01913
• Device Sequence Number: 1140981
• Product Code: MKJ
• UDI-Device Identifier: 00883873813744
• UDI-Public: 00883873813744
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K130454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2022

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: 20
• Device Catalogue Number: 99402-000016
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/22/2021
• Supplement Date Received by Manufacturer: 02/25/2022
• Initial Report FDA Received Date: 10/06/2021
• Supplement Report FDA Received Date: 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/25/2005
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 67 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White