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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
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PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number 15
Device Problems Electrical /Electronic Property Problem (1198); Unexpected Shutdown (4019)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/09/2024
Event Type  malfunction  
Event Description
The customer contacted stryker to report that their device had unexpectedly lost power.In addition, the customer noticed that the device's screen was locked-up.As a result, defibrillation would not be available, if needed.This issue is patient related; however there was no adverse patient outcome reported.
 
Manufacturer Narrative
Due to character limitations section e1, initial reporter phone, was left blank.The initial reporter¿s phone number is (b)(6).Stryker 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.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.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.
 
Event Description
The customer contacted stryker to report that their device had unexpectedly lost power.In addition, the customer noticed that the device's screen was locked-up.As a result, defibrillation would not be available, if needed.This issue is patient related; however there was no adverse patient outcome reported.
 
Manufacturer Narrative
Corrected data: section a1, patient identifier of the initial medwatch report indicates none; section a1, patient identifier of the initial medwatch report should indicate blank.Additional manufacturer narrative: stryker contacted the customer to request additional information on the patient.The customer informed stryker that no further patient information is available.Patient fields in which information is not provided were intentionally left blank.Stryker service representative evaluated the customer's device and was unable to duplicate the reported issue.Proper device operation was observed through functional and performance testing and the device was, subsequently, returned to the customer for use.
 
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Brand Name
LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
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 Key19133971
MDR Text Key340744207
Report Number0003015876-2024-00959
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K142430
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/07/2024
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
Device Operator Health Professional
Device Model Number15
Device Catalogue Number99577-001388
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/15/2024
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/10/2024
Initial Date FDA Received04/18/2024
Supplement Dates Manufacturer Received05/07/2024
Supplement Dates FDA Received05/07/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/30/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient SexFemale
Patient RaceWhite
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