| Catalog Number |
650605550002 |
| Medical Device Problem Code |
Difficult or Delayed Positioning (1157)
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| Health Effect - Clinical Code |
No Clinical Signs, Symptoms or Conditions (4582)
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Type of Reportable Event
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Malfunction
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Additional Manufacturer Narrative
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This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.12 device(s) was/were functionally/visually inspected in the field.The device(s) was/were repaired and returned to use.Evaluation results findings (components/results): 1 device: cover; fastener / device migration.1 device: circuit board; hydraulic system / electrical/electronic component problem identified; mechanical problem identified.1 device: fastener / mechanical problem identified.6 devices: chassis/frame / mechanical problem identified.1 device: rod/shaft / deformation problem.1 device: chassis/frame / device migration.1 device: spring / device migration.There was no remedial action taken.This device is not labeled for single use.
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Event or Problem Description
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This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Events occurred between october 1-december 31, 2025.This report summarizes 12 malfunction event(s), where it was reported the device experienced difficult to load/unload the cot in the ambulance.No adverse consequence or clinically relevant delay in treatment was reported.
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Additional Manufacturer Narrative
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Initially it was reported that there were 2 instances of this hazard/model number combination.Further review of records identified that one record was a duplicate.The number of events summarized have been updated to reflect this.
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Event or Problem Description
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This report now summarizes 11 malfunction event(s), instead of 12.
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Search Alerts/Recalls
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