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	01/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted spacelabs healthcare to request repair for an ariatele that failed to alarm.No patient or user harm was reported.Spacelabs healthcare technical support attempted to contact the customer for additional information regarding reported failure to alarm, however the customer has not responded to attempts to get additional information.The device has been received, however has not yet been evaluated.A follow-up report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.
Additional Manufacturer Narrative
The customer's device was returned to spacelabs healthcare for evaluation.The complaint condition was not verified.The ariatele was found to have a damaged case and broken battery connector.The broken parts were replaced, functional and performance testing was performed, and the device was returned to the customer for use.

• 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: 24408320
• Report Number: 3010157426-2026-00040
• Device Sequence Number: 9748476
• Product Code: MHX
• UDI-Device Identifier: 10841522100352
• UDI-Public: (01)10841522100352(11)231223
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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,Followup
• Report Date (Section B): 03/11/2026

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: 02/11/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2026
• Supplement Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2023
• 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