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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. HIGH FLOW INSUFFLATION UNIT
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SHIRAKAWA OLYMPUS CO., LTD. HIGH FLOW INSUFFLATION UNIT Back to Search Results
Model Number UHI-4
Device Problem Gas Output Problem (1266)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/14/2024
Event Type  malfunction  
Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported, the high flow unsufflation unit had no air, no co2 gas coming from the cylinder even when the cylinder was full.There was no procedure and no patient involvement.
 
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Brand Name
HIGH FLOW INSUFFLATION UNIT
Type of Device
HIGH FLOW INSUFFLATION UNIT
Manufacturer (Section D)
SHIRAKAWA OLYMPUS CO., LTD.
3-1 okamiyama
odakura, nishigo-mura,
nishishirakawa-gun, fukushima 961-8 061
JA  961-8061
Manufacturer (Section G)
SHIRAKAWA OLYMPUS CO., LTD.
3-1 okamiyama
odakura, nishigo-mura,
nishishirakawa-gun, fukushima 961-8 061
JA   961-8061
Manufacturer Contact
todd brill
800 west park drive
westborough, MA 01581
5082077661
MDR Report Key19218261
MDR Text Key341496640
Report Number3002808148-2024-04031
Device Sequence Number1
Product Code HIF
UDI-Device Identifier04953170324147
UDI-Public04953170324147
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K122180
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Nurse
Type of Report Initial
Report Date 04/30/2024
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 NumberUHI-4
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/14/2024
Initial Date FDA Received04/30/2024
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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