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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK CR(R) PLUS DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
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PHYSIO-CONTROL, INC. - 3015876 LIFEPAK CR(R) PLUS DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number CRPLUS
Device Problem No Audible Prompt/Feedback (2282)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/25/2021
Event Type  malfunction  
Manufacturer Narrative
Physio-control evaluated the customer's device and observed that the speaker was not working.The customer will be provided with a replacement device.Physio-control 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
A customer had sent in their device for service.Upon inspection, physio-control observed that the device's speaker was not working.As a result, no voice prompt would be available and without voice prompts, a lay user would not receive the audible instructions on how to properly use the device on a patient.There was no patient use associated with the reported event.
 
Event Description
A customer had sent in their device for service.Upon inspection, physio-control observed that the device's speaker was not working.As a result, no voice prompt would be available and without voice prompts, a lay user would not receive the audible instructions on how to properly use the device on a patient.There was no patient use associated with the reported event.
 
Manufacturer Narrative
The device can no longer be repaired.The customer was notified and the device was removed from service.A root cause could not be determined.
 
Manufacturer Narrative
Physio-control product analysis center (pac) evaluated the customer's device and verified that the speaker was non-functional the root cause of the reported issue was determined to be due to a faulty speaker assembly.
 
Event Description
A customer had sent in their device for service.Upon inspection, physio-control observed that the device's speaker was not working.As a result, no voice prompt would be available and without voice prompts, a lay user would not receive the audible instructions on how to properly use the device on a patient.There was no patient use associated with the reported event.
 
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Brand Name
LIFEPAK CR(R) PLUS DEFIBRILLATOR
Type of Device
AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Manufacturer (Section D)
PHYSIO-CONTROL, INC. - 3015876
11811 willows road ne
redmond WA 98052
MDR Report Key11664864
MDR Text Key245395196
Report Number0003015876-2021-00813
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
PMA/PMN Number
K033275
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial,Followup,Followup
Report Date 09/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCRPLUS
Device Catalogue Number99403-000219
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/16/2021
Date Manufacturer Received08/31/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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