MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LP15,EN,SPO2,12L,EX,NIBP,CO2,TR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	15
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Physio-control contacted the customer to request additional information on the patient.No response has been received from the customer.Patient fields in which information is not provided were intentionally left blank.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
The customer contacted physio-control to report that their device switched from paddles mode to lead mode at least twice.In this state the device would not be able to deliver defibrillation therapy if needed.This issue is patient related; however there was no adverse patient outcome reported.
Additional Manufacturer Narrative
The customer worked with a stryker tech support rep to troubleshoot over the phone.The device was not evaluated and the reported issue could not be verified.The customer suspected a bad trunk cable and was going to replace it.The customer confirmed that the trunk cable was replaced and the issue has not been duplicated since.The root cause is determined to be a bad trunk cable.H3 other text : device not returned to manufacturer.
Event or Problem Description
The customer contacted physio-control to report that their device switched from paddles mode to lead mode at least twice.In this state the device would not be able to deliver defibrillation therapy if needed.This issue is patient related; however there was no adverse patient outcome reported.

• Brand Name: LP15,EN,SPO2,12L,EX,NIBP,CO2,TR
• 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: 9609227
• Report Number: 0003015876-2020-00102
• Device Sequence Number: 19502569
• Product Code: MKJ
• UDI-Device Identifier: 00883873979358
• UDI-Public: 00883873979358
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K142430
• 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): 04/10/2020

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: 15
• Device Catalogue Number: 99577-000061
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/26/2019
• Supplement Date Received by Manufacturer: 03/30/2020
• Initial Report FDA Received Date: 01/20/2020
• Supplement Report FDA Received Date: 04/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1