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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD. QUANTUM VENTILATION MODULE; GAS CONTROL UNIT
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SPECTRUM MEDICAL LTD. QUANTUM VENTILATION MODULE; GAS CONTROL UNIT Back to Search Results
Model Number QVM
Device Problem Suction Problem (2170)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/17/2022
Event Type  malfunction  
Event Description
It was reported the ventilation module was having problems with the applied vacuum issues through out the week during cases.Their was no reported patient injury.
 
Manufacturer Narrative
Ventilation module was repaired by replacing vacuum regulator and returned to customer.No further issues have been reported.
 
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Brand Name
QUANTUM VENTILATION MODULE
Type of Device
GAS CONTROL UNIT
Manufacturer (Section D)
SPECTRUM MEDICAL LTD.
harrier 4 meteor business park
cheltenham rd east
gloucester, GL29Q L
UK  GL29QL
Manufacturer Contact
colleen powell
harrier 4 buiness park
cheltenham rd east
gloucester GL29Q
4412423870
MDR Report Key15299759
MDR Text Key305360295
Report Number3006073153-2022-00002
Device Sequence Number1
Product Code DTX
UDI-Device Identifier05060434420688
UDI-Public05060434420688
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K181942
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Remedial Action Repair
Type of Report Initial
Report Date 06/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberQVM
Device Catalogue Number51-000045-00
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/08/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/21/2022
Was Device Evaluated by Manufacturer? Yes
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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