MAUDE Adverse Event Report: SPECTRUM MEDICAL LIMITED HB-SO2 TWIN 2.0M SENSOR 9/16"(3/8 X 3/32) (PART OF THE QUANTUM WORKSTATION); MONITOR

Model Number	HBS4-200
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial investigation was not able to reproduce fault.The sensor was returned to oem for further investigation.
Event or Problem Description
User reported that their sao2 was reading 0 for 70% of the case.The user tried factory resetting the value but were continuously unsuccessful recalibrating.The user reported that this was affecting the pao2 reading for the entire case.At the end of the case the value spiked at 99 before working correctly for the very end of the case.

• Brand Name: HB-SO2 TWIN 2.0M SENSOR 9/16"(3/8 X 3/32) (PART OF THE QUANTUM WORKSTATION)
• 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: 20180948
• Report Number: 3006073153-2024-00056
• Device Sequence Number: 15544553
• Product Code: DRY
• UDI-Device Identifier: 05060434420602
• UDI-Public: 05060434420602
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K163657
• 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
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 09/10/2024

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: HBS4-200
• Device Catalogue Number: 51-000037-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2024
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown