MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD. HB-SO2 TWIN 2.0M SENSOR 9/16"(3/8 X 3/32); EXTRACORPOREAL BLOOD GAS/PH

Model Number	HBS4-200
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A sat/hgb probe was reported as displaying!!! for sao2 and hgb readings.The clinical team performed a hard reboot of the probe and tried it on a subsequent case with the same result.Unfortunately, this is being reported a week after the fact and the clinical team is not sure which qws this occurred on.
Additional Manufacturer Narrative
Device being returned, to be investigated on return.

• Brand Name: HB-SO2 TWIN 2.0M SENSOR 9/16"(3/8 X 3/32)
• Common Device Name: EXTRACORPOREAL BLOOD GAS/PH
• Manufacturer (Section D): SPECTRUM MEDICAL LTD.; ashville business park; commerce road; gloucester,, gloucestershire GL29S L; UK GL29SL
• Manufacturer (Section G): SPECTRUM MEDICAL LTD; ashville business park; commerce road; gloucester, gloucestershire GL29S L; UK GL29SL
• Manufacturer Contact: raffaella tommasini ; ashville business park; commerce road; gloucester, gloucestershire GL29S-L ; UK GL29SL
• MDR Report Key: 23334652
• Report Number: 3006073135-2025-00261
• Device Sequence Number: 9910087
• Product Code: DRY
• UDI-Device Identifier: 05060434420602
• UDI-Public: 05060434420602
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• 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: Repair
• Type of Report: Initial
• Report Date (Section B): 10/20/2025

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: HBS4-200
• Device Catalogue Number: 51-000037-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 10/20/2025
• Was Device Evaluated by Manufacturer? (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