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, 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 Obstruction of Flow (2423)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/08/2024
Event Type  malfunction  
Manufacturer Narrative
H10 g - contact office phone number: (b)(6).E1 - reporter phone number - (b)(6).
 
Event Description
Philips received a complaint by the customer on the v60 ventilator indicating that the device's breathing circuit is blocked.There was no patient involvement at the time the issue was discovered.There was no report of patient or user harm.
 
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
melissa rosko
1001 murry ridge lane
murrysville, PA 15668
7247330200
MDR Report Key19125432
MDR Text Key340577383
Report Number2518422-2024-20291
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 Other
Device Model NumberV60
Device Catalogue Number1076716
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 04/08/2024
Initial Date FDA Received04/17/2024
Date Device Manufactured06/10/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-