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

Model Number	QWS12E
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For (b)(6), the device was not returned and the wrong logs were provided by the customer, preventing an investigation.For (b)(6), the logs showed that the bubble detection intervention was disabled manually then reapplied 19s afterwards, indicating user error in a reasonably foreseeable manner.
Event or Problem Description
User reported two occasions of pump stoppage during a case.For the device (serial number: (b)(6), it was reported that the pump rpm decreased to 0 when zeroing the pin sensor.For the device (serial number: (b)(6), it was reported that the blood flow stopped when repositioning a sensor.In both cases the operation was continued with the devices and completed succesfully.

• Brand Name: QUANTUM WORKSTATION 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: 21282616
• Report Number: 3006073153-2025-00032
• Device Sequence Number: 21167157
• Product Code: DRY
• UDI-Device Identifier: 05060434422309
• UDI-Public: 5060434422309
• Combination Product (Y/N): N
• PMA/510(K) Number: K202557
• Exemption Number: VMSR
• 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): 01/31/2025

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2025
• 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