Model Number 6506 |
Device Problem
Positioning Failure (1158)
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Patient Problems
Muscle/Tendon Damage (4532); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2023 |
Event Type
malfunction
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Manufacturer Narrative
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This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.14 devices were functionally/visually inspected in the field.The devices were repaired and returned to use.1 device is pending evaluation.There was no remedial action taken.This device is not labeled for single use.
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Event Description
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This report summarizes 15 malfunction events, where it was reported the devices experienced cot height cannot be adjusted or fowler stuck elevated.There were 2 events with patient involvement; no adverse consequences were reported.There was 1 event with patient involvement the patient experienced minor injury/illness/impairment.
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Manufacturer Narrative
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The device that was pending evaluation was not made available by the customer; the reported issue was not confirmed.Section h codes have been updated to reflect this.
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Event Description
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This report summarizes 15 malfunction events, where it was reported the devices experienced cot height cannot be adjusted or fowler stuck elevated.There were 2 events with patient involvement; no adverse consequences were reported.There was 1 event with patient involvement the patient experienced muscle/tendon damage.
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Search Alerts/Recalls
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