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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR; DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)
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PHYSIO-CONTROL, INC LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR; DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) Back to Search Results
Model Number 20
Device Problem Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/19/2014
Event Type  malfunction  
Event Description
The customer reported that during a patient event where the patient was only being monitored, the screen on their device went all white.A white screen on this device is indicative of a device lockup and would not allow the device to be used on the patient.The patient was in recovery from the cath lab when this event occurred and did not require defibrillation.There was no additional patient information obtained.There was no adverse effect reported to have been caused to the patient as a result of the reported issue.
 
Manufacturer Narrative
(b)(4).Physio-control evaluated the device and was unable to verify the reported failure.Physio observed proper device operation through functional and performance testing and the device was returned to the customer for use.The cause of the reported failure could not be determined.(b)(4).Physio-control evaluated the device and was unable to verify the reported failure.Physio observed proper device operation through functional and performance testing and the device was returned to the customer for use.The cause of the reported failure could not be determined.
 
Manufacturer Narrative
(b)(4).Physio-control evaluated the device and was unable to verify the reported failure.Physio observed proper device operation through functional and performance testing and the device was returned to the customer for use.The cause of the reported failure could not be determined.
 
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Brand Name
LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR
Type of Device
DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)
Manufacturer (Section D)
PHYSIO-CONTROL, INC
11811 willows road ne
po box 97006
redmond WA 98073 970
Manufacturer (Section G)
PHYSIO-CONTROL, INC
11811 willows road ne
po box 97006
redmond WA 98073 970
Manufacturer Contact
jason march
4258674000
MDR Report Key4092671
MDR Text Key17291521
Report Number3015876-2014-01088
Device Sequence Number1
Product Code LDD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K063119
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 08/19/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/16/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number20
Device Catalogue Number3202487
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/29/2014
Is the Reporter a Health Professional? Yes
Device Age8 YR
Event Location Hospital
Date Manufacturer Received09/16/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/22/2006
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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