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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 15 DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
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PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 15 DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number 15
Device Problem Failure to Sense (1559)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/12/2023
Event Type  malfunction  
Event Description
The customer contacted stryker to report that their device failed during cardioversion.This issue has the potential to either delay, or prevent, defibrillation from being delivered.There was no report of patient harm associated with the reported event.
 
Manufacturer Narrative
Stryker 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.Stryker will not request any patient identifying information to be in accordance with regulation (eu) 2016/679 of the european parliament and of the council.Due to character limitations section e1, initial reporter phone, was left blank.The initial reporter¿s phone number is (b)(6).
 
Manufacturer Narrative
Stryker evaluated the customer's device and was unable to duplicate the reported issue, but was able to verify the reported issue was logged in the device¿s memory.After completing other unrelated repairs, proper device operation was observed through functional and performance testing.The device was returned to the customer for use.The cause of the reported issue could not be determined.
 
Event Description
The customer contacted stryker to report that their device failed during cardioversion.This issue has the potential to either delay, or prevent, defibrillation from being delivered.There was no report of patient harm associated with the reported event.
 
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Brand Name
LIFEPAK® 15 DEFIBRILLATOR/MONITOR
Type of Device
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
brian blakeslee
11811 willows road ne
redmond, WA 98052
4258674000
MDR Report Key18156598
MDR Text Key329266638
Report Number0003015876-2023-02135
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K142430
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/11/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number15
Device Catalogue Number99577-001392
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/25/2023
Date Manufacturer Received12/19/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/17/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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