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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 1000 DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

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PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 1000 DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number 1000
Device Problem Failure to Shut Off (2939)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/08/2022
Event Type  malfunction  
Manufacturer Narrative
Stryker evaluated the customer's device and was unable to duplicate or verify reported issue.After observing proper device operation 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 would not power off.In this state, the device hlc internal battery could experience premature depletion and so if needed, defibrillation (automated, manual or synchronized cardioversion) therapy may not be able to be delivered.There was no patient involvement reported with the event.
 
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Brand Name
LIFEPAK® 1000 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 Key15528798
MDR Text Key306338006
Report Number0003015876-2022-02197
Device Sequence Number1
Product Code MKJ
UDI-Device Identifier00883873815465
UDI-Public00883873815465
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P160026
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
Report Date 10/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/03/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number1000
Device Catalogue Number99425-000025
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/20/2022
Date Manufacturer Received09/08/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/26/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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