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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 QUIK-COMBO; ELECTRODE, ELECTROCARDIOGRAPH
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PHYSIO-CONTROL, INC. - 3015876 QUIK-COMBO; ELECTRODE, ELECTROCARDIOGRAPH Back to Search Results
Model Number 11996
Device Problem Failure to Sense (1559)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/11/2021
Event Type  malfunction  
Event Description
The customer contacted stryker to report that their device would not recognize defibrillation pads were connected.The customer tested device and believes the defibrillation electrodes were the issue.In this state the device would not be able to deliver defibrillation therapy if needed.This issue is patient related; however there was no adverse event reported.
 
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 contacted the customer to request additional information on the patient.No response has been received from the customer.
 
Manufacturer Narrative
Stryker evaluated the customer's lp 15 device - the electrodes were disposed of at the time of event and therefor not available for evaluation.The reported issue could not be duplicated and the cause could not be determined.After observing proper operation of the lp 15 device 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 would not recognize defibrillation pads were connected.The customer tested device and believes the defibrillation electrodes were the issue.In this state the device would not be able to deliver defibrillation therapy if needed.This issue is patient related; however there was no adverse event reported.
 
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Brand Name
QUIK-COMBO
Type of Device
ELECTRODE, ELECTROCARDIOGRAPH
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 Key12954929
MDR Text Key282104601
Report Number0003015876-2021-02304
Device Sequence Number1
Product Code DRX
UDI-Device Identifier00883873784969
UDI-Public00883873784969
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K943301
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 01/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/10/2022
Device Model Number11996
Device Catalogue Number11996-000017
Device Lot Number922451
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/20/2021
Date Manufacturer Received12/20/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/10/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
LIFEPAK® 15 DEFIBRILLATOR/MONITOR, MJK, SN (B)(6).
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