• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, LLC RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

RESPIRONICS CALIFORNIA, LLC RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE Back to Search Results
Model Number V60 VENT, JAPAN OPT: CFLEX,AVAPS,AT+
Device Problems Defective Alarm (1014); Calibration Problem (2890)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/12/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
A customer was performing a post-use check in the hospital's clinical engineer room and found that a check vent alarm had occurred and contacted philips.The device was in clinical use at the time of the event however, there was no report of patient or user harm and neither delay in therapy nor medical intervention reported.The reported issue was not duplicated by a test run performed.Occurrence records of "check vent: primary alarm failed (diagnostic code:1102) (power speaker fail, motor speaker fail)" and "check vent: cpu pcba adc failed (diagnostic code:111e) were confirmed in the event log.The central processing unit (cpu) board and speaker#1 and speaker#2 were replaced to prevent recurrence.Unit was cleaned, run-in and functionally tested.
 
Manufacturer Narrative
A central processing unit (cpu) and 2 speakers were returned for failure analysis.An investigation was performed, and the returned cpu ran for extended period in power-cycled environment and no errors occurred.An investigation was performed on the returned speakers and the returned speakers operated normally on bench and in ventilator.There were no faults found on the returned parts.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
RESPIRONICS
Type of Device
VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
Manufacturer (Section D)
RESPIRONICS CALIFORNIA, LLC
2271 cosmos court
carlsbad CA 92011
Manufacturer (Section G)
RESPIRONICS CALIFORNIA, LLC
2271 cosmos court
carlsbad CA 92011
Manufacturer Contact
melissa abbott
2271 cosmos court
carlsbad, CA 92011
7609187300
MDR Report Key13170369
MDR Text Key283270295
Report Number2031642-2022-00057
Device Sequence Number1
Product Code MNT
UDI-Device Identifier00884838033832
UDI-Public00884838033832
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K102985
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberV60 VENT, JAPAN OPT: CFLEX,AVAPS,AT+
Device Catalogue Number1076709
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/12/2021
Initial Date FDA Received01/05/2022
Supplement Dates Manufacturer Received03/31/2022
Supplement Dates FDA Received08/16/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/05/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-