MAUDE Adverse Event Report: SPECTRUM MEDICAL LIMITED QUANTUM WORKSTATION 12 ELITE; BLOOD GAS MONITOR

Model Number	QWS12E
Medical Device Problem Code	Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The review of the logs did not find any conclusive evidence.The visual inspection found specks of debris in between the screen layers.In addition, a split on the gnd wire was found, although this did not appear to short out during testing.Furthermore, the conductive tubing was missing of the front screen assembly.This was an error of the manufacturing and assembly process.It is not clear what local external influence interference there was at the time of failure.Therefore, a number of factors could have contributed to the error seen and no conclusive findings were able to be drawn.
Event or Problem Description
Perfusionist reported that the screen froze during a case, which led to the pump speed accidentally being adjusted to 6000 rpm.This was able to be rectified immediately and the case completed successfully.We conder inability to control the pump to be reportable, despite no harm to the patient involved.

• Brand Name: QUANTUM WORKSTATION 12 ELITE
• Common Device Name: BLOOD GAS MONITOR
• Manufacturer (Section D): SPECTRUM MEDICAL LIMITED; harrier4, meteor business park; cheltenham road east; gloucester, gloucestershire GL2 9 QL; UK GL2 9QL
• Manufacturer (Section G): SPECTRUM MEDICAL LIMITED; harrier4, meteor business park; cheltenham road east; gloucester, gloucestershire GL2 9 QL; UK GL2 9QL
• Manufacturer Contact: edward blogg ; harrier4, meteor business park; cheltenham road east; gloucester, gloucestershire GL2 9-QL ; UK GL2 9QL
• MDR Report Key: 20817090
• Report Number: 3006073153-2024-00113
• Device Sequence Number: 8716862
• Product Code: DRY
• UDI-Device Identifier: 05060434422309
• UDI-Public: 05060434422309
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K202557
• 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
• Type of Report: Initial
• Report Date (Section B): 12/02/2024

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
• Operator of Device: Health Professional
• Device Model Number: QWS12E
• Device Catalogue Number: 51-000094-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/21/2023
• Initial Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2021
• 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