MAUDE Adverse Event Report: SPACELABS HEALTHCARE ARIATELE TELEMETRY TRANSMITTER

Model Number	96281
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Hypoxia (1918)
Date of Event	12/31/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported to spacelabs healthcare that a patient incident occurred with an ariatele device.During the event, the patient appeared to be hypoxic despite no indications of low oxygen saturation by the ariatele.This was noticed by clinical staff and a secondary handheld pulse oximeter was used to confirm the patient was hypoxic.Treatment was administered and the patient survived.During troubleshooting, the technical support representative confirmed that the customer was using an sp02 sensor which is not compatible with the ariatele transmitter.The customer was provided documentation that states the sensor was incompatible and to only use approved sensors going forward.The cause of the reported issue was due to the use of incompatible sp02 sensors which provided inaccurate results.

• Brand Name: ARIATELE TELEMETRY TRANSMITTER
• Common Device Name: TELEMETRY TRANSMITTER
• Manufacturer (Section D): SPACELABS HEALTHCARE; 35301 se center st; snoqualmie WA 98065
• Manufacturer (Section G): SPACELABS HEALTHCARE; 35301 se center st; snoqualmie WA 98065
• Manufacturer Contact: whitney snyder ; 35301 se center st; snoqualmie, WA 98065
• MDR Report Key: 24229104
• Report Number: 3010157426-2026-00012
• Device Sequence Number: 13329469
• Product Code: MHX
• UDI-Device Identifier: 10841522100352
• UDI-Public: (01)10841522100352
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K121480
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 01/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 96281
• 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: 12/31/2025
• Initial Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown