MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LP15,EN,SPO2,3L,EX,NIBP,CO2,TR,VR,V4; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	15
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	Ventricular Fibrillation (2130)
Date of Event	06/11/2021
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 performed an initial evaluation of the customer device and verified the reported issue.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's screen froze for 10 seconds while in use.This issue is patient related, the user reported they could not determine the patient's ecg rhythm or provide defibrillation if needed; however no serious injury or death has been reported at this time.
Event or Problem Description
The customer contacted physio-control to report that their device's screen froze for 10 seconds while in use.This issue is patient related, the user reported they could not determine the patient's ecg rhythm or provide defibrillation if needed; however no serious injury or death has been reported at this time.
Additional Manufacturer Narrative
Initial mfr# 0003015876-2021-01381 stated that the reported issue was verified, however the investigation determined that the reported issue was neither verified nor duplicated.Root cause was unable to be determined.The battery pins were replaced as per pip process.The device passed functional and performance testing and was returned to the customer.

• Brand Name: LP15,EN,SPO2,3L,EX,NIBP,CO2,TR,VR,V4
• 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: 12131397
• Report Number: 0003015876-2021-01381
• Device Sequence Number: 11956303
• Product Code: MKJ
• UDI-Device Identifier: 00883873872079
• UDI-Public: 00883873872079
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P160026
• 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): 10/15/2021

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: 99577-001932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Initial Date Received by Manufacturer: 06/11/2021
• Supplement Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 07/07/2021
• Supplement Report FDA Received Date: 10/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1