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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 Problem Material Fragmentation (1261)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/01/2022
Event Type  malfunction  
Manufacturer Narrative
Stryker continues to investigate the reported issue 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 battery retainer was broken and both batteries were unable to be locked into the battery wells.In this state, defibrillation therapy may be delayed or prevented from being delivered to the patient if needed.There was no patient use associated with the reported event.
 
Manufacturer Narrative
Stryker evaluated the customer's device and verified the reported issue.Stryker determined that the cause of the reported issue was due to a broken battery retainer in the rear case.Stryker replaced the battery retainer to resolve the issue.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.
 
Event Description
The customer contacted stryker to report that their device battery retainer was broken and both batteries were unable to be locked into the battery wells.In this state, defibrillation therapy may be delayed or prevented from being delivered to the patient if needed.There was no patient use associated with the reported event.
 
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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
todd bandy
11811 willows road ne
redmond, WA 98052
4258674000
MDR Report Key15775000
MDR Text Key303634436
Report Number0003015876-2022-02486
Device Sequence Number1
Product Code MKJ
UDI-Device Identifier00883873871690
UDI-Public00883873871690
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142430
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 02/20/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number15
Device Catalogue Number99577-001957
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received02/14/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/18/2015
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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