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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, LLC RESPIRONICS; VENTILATOR, CONTINUOUS, FACILITY USE
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RESPIRONICS CALIFORNIA, LLC RESPIRONICS; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number V200
Device Problem Power Problem (3010)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/25/2021
Event Type  malfunction  
Manufacturer Narrative
The customer reported there was no patient involvement.
 
Event Description
The customer reported that the unit had an error message of post timer/24v failure.The customer reported there was no patient involvement.The customer was instructed to remove the top cover and confirm no cables are pinched.The customer reported that no pinched cables were observed, and the unit will not enter extended self-test (est).
 
Manufacturer Narrative
B4:26aug2021.The field service engineer (fse) confirmed the reported failure.After replacing a flow sensor, the (fse) was troubleshooting the unit at the shop when the power supply went out with diagnostic error code "post timer/24v failure." the fse ordered a power supply to fix the unit; however, the unit was at its end of life (eol).The fse could not repair the unit because it was at its eol.The fse has decided to retire unit from service.
 
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Brand Name
RESPIRONICS
Type of Device
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
RESPIRONICS CALIFORNIA, LLC
2271 cosmos court
carlsbad CA 92011
MDR Report Key11577505
MDR Text Key242711700
Report Number2031642-2021-03142
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
PMA/PMN Number
K102054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberV200
Device Catalogue Number1060264
Was Device Available for Evaluation? Yes
Distributor Facility Aware Date02/25/2021
Date Manufacturer Received07/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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