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: HUDSON DISP MANUAL RESUS,ADULT W/FLOW DIVERTER; VENTILATOR, EMERGENCY, MANUAL
  • 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
 

HUDSON DISP MANUAL RESUS,ADULT W/FLOW DIVERTER; VENTILATOR, EMERGENCY, MANUAL Back to Search Results
Model Number IPN039351
Device Problem Unintended Deflation (4061)
Patient Problem Insufficient Information (4580)
Event Date 01/25/2021
Event Type  malfunction  
Manufacturer Narrative
Qn#(b)(4).
 
Event Description
It was reported "the respiratory department is having complaints that the face cushion goes flat and they can not use them".Unknown if the device was in use on a patient at the time of the event.
 
Manufacturer Narrative
Qn# (b)(4).Additional information received indicates the issue was detected prior to use on the patient.The sample was returned and sent to the manufacturer (galemed) for investigation.Galemed reports: "a little air was left in the air cushion, when immerging the mask into the water, we could not see any bubbles leaked from the mask.After long time storage, the air in the cushion will leak naturally.Basing on the limited information (no lot no.) we got at present, we considered that it was a single case.".
 
Event Description
It was reported "the respiratory department is having complaints that the face cushion goes flat and they can not use them".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HUDSON DISP MANUAL RESUS,ADULT W/FLOW DIVERTER
Type of Device
VENTILATOR, EMERGENCY, MANUAL
MDR Report Key11344077
MDR Text Key232742334
Report Number3011137372-2021-00027
Device Sequence Number1
Product Code BTM
UDI-Device Identifier14026704662682
UDI-Public14026704662682
Combination Product (y/n)N
PMA/PMN Number
K964719
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 01/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberIPN039351
Device Catalogue Number5372
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/25/2021
Date Manufacturer Received06/04/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-