Xhibit Telemetry Receiver (Xtr) 96280 V.1.4.0
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|Xhibit Telemetry Receiver (Xtr) 96280 V.1.4.0
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An error associated with the operating system causes this defect. After approximately 25 days of continuous use, technical alarm escalation does not occur as specified and expected. All clinical alarms functions as intended and initial technical alarms initiate as intended, but the technical alarm escalation, which occurs after a technical alarm continues for an additional time, does not occur. The fact that this involves technical alarms and not clinical alarm drove the difficulty in more timely recognition of the potential safety risk associated with this defect. The safety concern is based upon the potential that a caregiver may not respond to the initial alarm and is not made aware of the continuing technical failure because of the failure of the secondary (the escalating) alarm. A patient event could occur and without the escalation to indicate a higher severity, the delayed or lack of response from the caregiver could result in injury or death of the patient. In addition, if the alarm acknowledge feature is used, there would be no breakthrough reminder to the caregiver in the form of an alarm escalation. Technical alarms include: 1. all leads off, 2. low battery, 3. signal loss, 4. signal interference, and 5. spo2 sensor off. As notable from the associated complaints, many customers have detected the issue, but no occurrence have led to any harm.
Recall start date: June 2, 2022
Spacelabs Healthcare Inc.
35301 Se Center Street, Snoqualmie, Washington, United States, 98065