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

Model Number	QWS12E
Medical Device Problem Code	Increased Pump Speed (1501)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation found that the workstation had intermittent loss of communication with the pump, which caused the issue with the pump speed.The root cause could not be assessed further.
Event or Problem Description
User reported an unexpected pump speed increase to 6000 rpm.The user reported that the issue "fixed itself" a minute after.We consider unexpected pump increase a reportable malfunction.

• Brand Name: QUANTUM WORKSTATION 12" ELITE
• Common Device Name: MONITOR
• Manufacturer (Section D): SPECTRUM MEDICAL LIMITED; harrier4, meteor business park; cheltenham road east; gloucester, gloucestershire GL29Q L; UK GL29QL
• Manufacturer (Section G): SPECTRUM MEDICAL LIMITED; harrier4, meteor business park; cheltenham road east; gloucester, gloucestershire GL29Q L; UK GL29QL
• Manufacturer Contact: angus fletcher ; harrier4, meteor business park; cheltenham road east; gloucester, gloucestershire GL29Q-L ; UK GL29QL
• MDR Report Key: 20818960
• Report Number: 3006073153-2024-00116
• Device Sequence Number: 7683329
• Product Code: DRY
• UDI-Device Identifier: 05060434422293
• UDI-Public: 05060434422293
• 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
• Remedial Action: Replace
• 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: 10/08/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2021
• 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