MAUDE Adverse Event Report: SPACELABS HEALTHCARE XHIBIT TELEMETRY RECEIVER

Model Number	96280
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Note regarding b4, udi field: only the gtin information for the reported device was provided as the serial number was not available.
Event or Problem Description
The customer reported that they had a failure to alarm for a ventricular tachycardia.Due to the delay in the customer reporting the event to spacelabs healthcare, waveform data was no longer able to be reviewed as the data had been purged.Additionally, it was unclear which xhibit telemetry receiver (xtr) was involved with the event.A spacelabs healthcare field service engineer (fse) went on site to evaluate all the xtrs at the customers site that could have been associated with the event.All of the xtrs passed functional and performance testing.The fse gathered xtr logs and forwarded to a spacelabs healthcare product support specialist for additional review.When the review of data is complete, a follow up report will be submitted in accordance with 21 cfr 803.56.
Additional Manufacturer Narrative
The xhibit telemetry receiver (xtr) logs were pulled and evaluated by a spacelabs healthcare product support specialist (pss).The pss found that the channel on the xtr was in noise shut down and temporarily stopped processing ecg.The noise shut down occurs when there is significant noise in the ecg.The system will alert clinical staff of the noisy waveform, however, this will cause ecg to temporarily stop processing the waveforms and identify arrhythmias until the noise is resolved.Data provided by the customer shows that the vtach occurred right after the noise.As the xtr was still in noise shut down, the system did not classify the ventricular tachycardia.

• Brand Name: XHIBIT TELEMETRY RECEIVER
• Common Device Name: TELEMETRY RECEIVER
• 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: 22352731
• Report Number: 3010157426-2025-00111
• Device Sequence Number: 18306604
• Product Code: MHX
• UDI-Device Identifier: 10841522100246
• UDI-Public: (01)10841522100246
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K141156
• 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): 07/24/2025

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: 96280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2025
• Supplement Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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