Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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, CHINA OPT: CFLEX, AVAPS
Device Problem Unable to Obtain Readings (1516)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/05/2022
Event Type  malfunction  
Event Description
The customer reported they cannot measure the data.It is unknown if the unit was in patient use at the time of the reported issue.No patient or user harm was reported.The service engineer says the data will appear once it is turned on.Suggested checking the data acquisition (da) board.The customer declined service.Based on information provided and/or service performed, the customer's alleged malfunction was not confirmed.The root cause cannot be determined.
 
Manufacturer Narrative
Reporting institution phone: (b)(6).Reporter phone number: (b)(6).
 
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
kimberly shelly
2271 cosmos court
carlsbad, CA 92011
7609187300
MDR Report Key15076063
MDR Text Key296341090
Report Number2031642-2022-01909
Device Sequence Number1
Product Code MNT
UDI-Device Identifier00884838025776
UDI-Public00884838025776
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K102985
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other
Type of Report Initial
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, CHINA OPT: CFLEX, AVAPS
Device Catalogue Number1076716
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/05/2022
Initial Date FDA Received07/21/2022
Date Device Manufactured11/10/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-