MAUDE Adverse Event Report: SPACELABS HEALTHCARE ARIATELE TELEMETRY TRANSMITTER

Model Number	96281
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted spacelabs healthcare to report that they had an ariatele transmitter that had an alarm that was not working properly.Spacelabs healthcare technical support made several attempts to get additional information regarding the alarm issue; however, no further details were available.The customer shipped the device to spacelabs healthcare for depot repair.The unit was tested by an equipment servce center technician.The technician could not verify the problem of 'will not alarm' because the device is not capable of producing alarms.However, did verify a display related failure.The unit had a faulty display pcb causing a blank screen and damage to the case.The unit was repaired and after passing all final functional testing, the unit was returned to the customer.

• 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: 24031212
• Report Number: 3010157426-2026-00001
• Device Sequence Number: 13133401
• Product Code: MHX
• UDI-Device Identifier: 10841522100352
• UDI-Public: (01)10841522100352(11)240613
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 01/09/2026

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: 96281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2024
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown