MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD QUANTUM WORKSTATION 12" ELITE; CONSOLE/PATIENT MONITOR

Model Number	QWS12E
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	08/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event logs were reviewed.Logs confirmed user selected zero flow and zero rpm.System operated as expected i.E., it's confirmed through the logs that the customer action was the reason the pump was set to zero flow and zero rpms were confirmed by the flow alarm.Spectrum medical personnel followed up with the ecmo coordinator again on 9/24/24 and they said everything was "all good" on their end and they didn't have any further questions or concerns.Log snippet sent to the ecmo coordinator on 8/21/24.
Event or Problem Description
An ecmo coordinator from ucsd medical center sent an email reporting an incident with a quantum elite going to zero rpm without anyone making any changes to the patient or the machine.There was a low flow alarm that was heard by the bedside ecmo specialist and when he went inside the patient room, the elite was found at zero rpm.The patient saturations dropped from 99% to 94% briefly but other than that patient was stable, no issues, and was being weaned off support towards decannulation.

• Brand Name: QUANTUM WORKSTATION 12" ELITE
• Common Device Name: CONSOLE/PATIENT MONITOR
• Manufacturer (Section D): SPECTRUM MEDICAL LTD; harrier4, meteor business park; cheltenham road east; gloucester, GL2 9 QL; UK GL2 9QL
• Manufacturer (Section G): SPECTRUM MEDICAL LTD; harrier4, meteor business park; cheltenham road east; gloucester, GL2 9 QL; UK GL2 9QL
• Manufacturer Contact: asia lukuc ; harrier4, meteor business park; cheltenham road east; gloucester, GL2 9-QL ; UK GL2 9QL
• MDR Report Key: 20319890
• Report Number: 3006073153-2024-00063
• Device Sequence Number: 8147100
• Product Code: DRY
• UDI-Device Identifier: 05060434422309
• UDI-Public: 05060434422309
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/26/2024

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?: No
• 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: 08/19/2024
• Initial Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown