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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LP15,EN,SPO2,3L,EX,NIBP,CO2,TR,VR,V4; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
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PHYSIO-CONTROL, INC. - 3015876 LP15,EN,SPO2,3L,EX,NIBP,CO2,TR,VR,V4; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number 15
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem Ventricular Fibrillation (2130)
Event Date 06/11/2021
Event Type  malfunction  
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 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 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.
 
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.
 
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Brand Name
LP15,EN,SPO2,3L,EX,NIBP,CO2,TR,VR,V4
Type of Device
AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Manufacturer (Section D)
PHYSIO-CONTROL, INC. - 3015876
11811 willows road ne
redmond WA 98052
MDR Report Key12131397
MDR Text Key260462366
Report Number0003015876-2021-01381
Device Sequence Number1
Product Code MKJ
UDI-Device Identifier00883873872079
UDI-Public00883873872079
Combination Product (y/n)N
PMA/PMN Number
P160026
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 10/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number15
Device Catalogue Number99577-001932
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/21/2021
Date Manufacturer Received09/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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