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

MAUDE Adverse Event Report: RESPIRONICS, INC. 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, INC. RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE Back to Search Results
Model Number V60
Device Problem Tidal Volume Fluctuations (1634)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/11/2024
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
Philips received a complaint from the customer reporting the v60 ventilator did not achieve the prescribed tidal volume setting.The device was reported to be in clinical use.There was no report of harm or other patient impact.The device did not meet specification for intended use and was removed from service.Investigation ongoing.
 
Manufacturer Narrative
A philips authorized service provider (asp) reported the reported issue was confirmed and determined to be due to a patient circuit issue.When the issue occurred, the device was exchanged for another ventilator to continue patient therapy.The patient circuit (breathing tube) was replaced by the customer.The device was operational and returned to service after repairs were completed.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.
 
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, INC.
1001 murry ridge lane
murrysville PA 15668
Manufacturer (Section G)
RESPIRONICS, INC.
1001 murry ridge lane
murrysville PA 15668
Manufacturer Contact
kimberly shelly
1001 murry ridge lane
murrysville, PA 15668
7247330200
MDR Report Key18940749
MDR Text Key338131681
Report Number2518422-2024-14496
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,Health Professional
Reporter Occupation Physician
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
Device Catalogue Number1076716
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/11/2024
Initial Date FDA Received03/20/2024
Supplement Dates Manufacturer Received04/27/2024
Supplement Dates FDA Received04/02/2024
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-