Model Number 2796 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
Injury
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Manufacturer Narrative
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Customer confirmed the product will not be returning for analysis.Therefore, this event is reported based on the information provided by the customer and from historical data of similar complaint.Sample and complaint recreation confirmed the reported issue.As such, ongoing investigation is underway to determine the root cause.Manufacturing reference file #(b)(4).Product will not be returning.
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Event Description
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Customer reported an event where the strap slipped through the d-ring attachment.The patient was still restrained within the cuffs but was allowed enough free mobility on the bed.Customer also reported that staff was nearby and was able to re-restrain the patient but that it took a longer duration.The date the issue was discovered is unknown and no patient incident or injury was reported.
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Manufacturer Narrative
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Voluntary corrective action recall is being performed to prevent a possible hazard to patients and caregivers, as the patients may self-release from restraints.Upon investigation, it was discovered that the twice-as-tough cuffs exhibit inadequate pull-strength that may allow for the strap to slip through the d-rings.This slippage may result in loosening of the patient¿s wrist(s) and/or ankle(s), providing a potential safety risk to the patient or the caregiver.The product is being replaced with product which meets the required pull-strength.A corrective and preventive action has been initiated.Manufacturer reference file # (b)(4).
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Event Description
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Supplemental needed for additional information.
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Search Alerts/Recalls
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