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: TRI-ANIM HEALTH SERVICES INC. HUMIDIFIER HIGH FLOW, BUBBLE; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
  • 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
 

TRI-ANIM HEALTH SERVICES INC. HUMIDIFIER HIGH FLOW, BUBBLE; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) Back to Search Results
Catalog Number 301-P3050EA
Device Problems Break (1069); Noise, Audible (3273)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/02/2018
Event Type  malfunction  
Event Description
Writer entered patient's room because the patients call light was on, i noted that there was a strange sound coming from the patients intermediate high flow o2 canister, i attempted to stop the sound but was unsuccessful.I immediately called respiratory and the respiratory therapist came up to the floor.When we tried to fix the canister we recognized that the connector piece from the intermediate high flow o2 canister and the wall mounted o2 regulator was broken.The entire canister was replaced and the canister was sent down.The piece was completely snapped.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HUMIDIFIER HIGH FLOW, BUBBLE
Type of Device
HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
Manufacturer (Section D)
TRI-ANIM HEALTH SERVICES INC.
5000 tuttle crossing blvd.
dublin OH 43016
MDR Report Key7498158
MDR Text Key107735128
Report Number7498158
Device Sequence Number1
Product Code BTT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 05/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number301-P3050EA
Other Device ID NumberMANUFACTURE CODE: TANM
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/04/2018
Event Location Hospital
Date Report to Manufacturer05/04/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NO
-
-