XHIBIT TELEMETRY RECEIVER
Report
- Report Number
- 3010157426-2022-00048
- Event Type
- Malfunction
- Date Received
- October 25, 2022
- Date of Event
- September 26, 2022
- Report Date
- September 26, 2022
- Manufacturer
- SPACELABS HEALTHCARE
- Product Code
- MHX
- PMA / PMN Number
- K141156
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
A SPACELABS TECHNICAL SUPPORT ENGINEER EVALUATED THE XHIBIT TELEMETRY RECEIVER (XTR) LOGS AND FOUND THAT AT 13:06 ON (B)(6) 2022, XTR15 HAD REBOOTED ITSELF AFTER IT WAS UNABLE TO COMMUNICATE WITH QUAD RECEIVER CARD (QRC) 1. THERE IS NOT ENOUGH INFORMATION AVAILABLE IN THE LOG FILES TO DETERMINE THE EXACT CAUSE OF THE COMMUNICATION ISSUE BETWEEN THE XTR AND QRC. A SPACELABS FIELD SERVICE ENGINEER (FSE) EVALUATED THE SYSTEM AND WAS UNABLE TO DUPLICATE THE REPORTED ISSUE. IT WAS FOUND THAT THE QRCS WERE WORKING AS EXPECTED. AFTER OBSERVING PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING, THE DEVICE WAS RETURNED TO THE CUSTOMER. AT THIS TIME, THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.
SPACELABS HEALTHCARE WAS NOTIFIED THAT THEIR XHIBIT TELEMETRY RECEIVER (XTR) HAD RESTARTED UNEXPECTEDLY AND BRIEFLY LOST CONNECTION WITH THE XHIBIT CENTRAL STATION. IT WAS ALSO NOTED THAT THE THERE WERE 4 TELEMETRY BEDS THAT HAD REVERTED TO THEIR DEFAULT COLOR SETTINGS, INDICATING THE SYSTEM HAD POWERED CYCLED. THERE WAS NO HARM TO THE PATIENT OR USER REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2776006 | XHIBIT TELEMETRY RECEIVER | TELEMETRY RECEIVER | MHX | SPACELABS HEALTHCARE | 96280 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |