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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HUDSON DISP MANUAL RESUS,ADULT W/FLOW DIVERTER; VENTILATOR, EMERGENCY, MANUAL
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HUDSON DISP MANUAL RESUS,ADULT W/FLOW DIVERTER; VENTILATOR, EMERGENCY, MANUAL Back to Search Results
Catalog Number 45372
Device Problem Complete Blockage (1094)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/25/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Customer reported the valves on the device were blocked and as a result the bag could not be compressed.It was reported "increased pressure was applied on the bag and thus the valves opened again and the functionality was given".The issue was discovered prior to use and another device was available for patient use.No patient harm or consequence reported.Patient reported to be "fine".
 
Manufacturer Narrative
Qn#(b)(4).The sample was returned and sent to the manufacturer (galemed) for investigation.Galemed reports a visual exam was performed and it was observed that the duckbill valve could not be fully opened.It was also reported that a 100% inspection on cosmetic and inspiratory and expiratory resistance tests were given at the assembly line; thus, any defect would be detected prior to release from the manufacturing facility.It was determined that the duckbill valve became sticky during the transportation and storage by accident.
 
Event Description
Customer reported the valves on the device were blocked and as a result the bag could not be compressed.It was reported "increased pressure was applied on the bag and thus the valves opened again and the functionality was given".The issue was discovered prior to use and another device was available for patient use.No patient harm or consequence reported.Patient reported to be "fine".
 
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Brand Name
HUDSON DISP MANUAL RESUS,ADULT W/FLOW DIVERTER
Type of Device
VENTILATOR, EMERGENCY, MANUAL
MDR Report Key9834994
MDR Text Key191039176
Report Number3011137372-2020-00088
Device Sequence Number1
Product Code BTM
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,foreig
Type of Report Initial,Followup
Report Date 03/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date04/28/2021
Device Catalogue Number45372
Device Lot Number180428
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/18/2020
Date Manufacturer Received04/15/2020
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
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