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

Model Number	HBS4-200
Medical Device Problem Code	Sensing Intermittently (1558)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The perfusionist called today to inform that during a case yesterday the sensor worked intermittently.This morning it started by working normally then stopped.They restarted the unit, changed location of the sensor, checked for irregularities but it was not going on again.No visible damage is seen on the sensor, no change in the usual consumables, light on both heads of the sensor still flashing.No patient harm reported and no impact to patient safety.
Additional Manufacturer Narrative
Device being returned to manufacturer, to be investigated on return.
Additional Manufacturer Narrative
During investigation it was noticed that the optical cable of the red sensor is damaged internally, when the cable is twisted it is possible to reproduce the issue and hear the optical cable making clicking noise as when the optical fibre is broken.Root cause determined to be accidental damage, replacement device provided.Device beyond economic repair and disposed of.No further action required.
Event or Problem Description
The perfusionist called today to inform that during a case yesterday the sensor worked intermittently.This morning it started by working normally then stopped.They restarted the unit, changed location of the sensor, checked for irregularities but it was not going on again.No visible damage is seen on the sensor, no change in the usual consumables, light on both heads of the sensor still flashing.No patient harm reported and no impact to patient safety.

• Brand Name: HB-SO2 TWIN 2.0M SENSOR 9/16"(3/8 X 3/32)
• Common Device Name: EXTRACORPOREAL BLOOD GAS/PH MONITOR
• 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: 23323567
• Report Number: 3006073135-2025-00259
• Device Sequence Number: 21319301
• Product Code: DRY
• UDI-Device Identifier: 05060434420602
• UDI-Public: 05060434420602
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 10/17/2025

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2025
• Supplement Date Received by Manufacturer: 10/03/2025
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2023
• 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