MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD. QUANTUM VENTILATION MODULE; GAS CONTROL UNIT

Model Number	QVM
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2022
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional Manufacturer Narrative
Ventilation module was repaired by replacing vacuum regulator and returned to customer.No further issues have been reported.

• Brand Name: QUANTUM VENTILATION MODULE
• Common Device Name: 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 Key: 15299759
• Report Number: 3006073153-2022-00002
• Device Sequence Number: 7307240
• Product Code: DTX
• UDI-Device Identifier: 05060434420688
• UDI-Public: 05060434420688
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K181942
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 06/21/2022

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
• Operator of Device: Health Professional
• Device Model Number: QVM
• Device Catalogue Number: 51-000045-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2022
• Initial Report FDA Received Date: 08/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown