Model Number TRSX5 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
Choking (2464)
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Event Date 01/26/2016 |
Event Type
Injury
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Manufacturer Narrative
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Should additional information become available, a supplemental record will be filed.All invacare arm rests for trsx5 come equipped with clothing guards.User¿s manual review (1110550 rev.H, page 16) safety and handling of the wheelchair require the close attention of the wheelchair user as well as the assistant.
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Event Description
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The provider states the end user's shirt was caught in the mechanism of the 1-arm drive and the shirt wrapped around the chair strangling the end user.The provider states there was someone there to help the end user to get free and the consumer was wearing a flowing or long shirt.The caller was inquiring about a potential cover for the mechanism to prevent this issue from occurring again.The caller states the end user cannot communicate to get help if needed and someone had noticed the material being pulled up around the consumers neck to assist.Update from 02/02/2016 added by consumer affairs: no malfunction alleged to one arm drive, clothing just got tangled in it and dealer was inquiring if there is a cover or something to keep clothing from wrapping around the one arm drive.No medical intervention.Update from 02/03/2016 added by consumer affairs: the dealer confirmed clothing guards were still on the chair at the time of the incident.Tech service also confirmed the chair was shipped with clothing guards and that we use clothing guards with a one arm drive.
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Manufacturer Narrative
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Product was returned for evaluation.The return fields in (b)(4) state: standard wheelchairs.Other, hold for detailed evaluation.Product received expanded evaluation.The expanded evaluation report states: utilizing existing complaint information, actual observations, and functional testing of the returned product in its "as received" condition, the complaint was not confirmed for any failure with the chair.No problems were found with the chair and it performed as intended.Complaint was not confirmed.The underlying cause could not be determined after reviewing the documentation in this investigation.
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Event Description
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Product was returned for evaluation.The return fields in (b)(4) state: standard wheelchairs.Other, hold for detailed evaluation.Product received expanded evaluation.The expanded evaluation report states: utilizing existing complaint information, actual observations, and functional testing of the returned product in its "as received" condition, the complaint was not confirmed for any failure with the chair.No problems were found with the chair and it performed as intended.The provider states the end users shirt was caught in the mechanism of the 1-arm drive and the shirt wrapped around the chair strangling the end user.The provider states there was someone there to help the end user to get free and the consumer was wearing a flowing or long shirt.The caller was inquiring about a potential cover for the mechanism to prevent this issue from occurring again.The caller states the end user cannot communicate to get help if needed and someone had noticed the material being pulled up around the consumers neck to assist.Update from 02/02/2016 added by consumer affairs: no malfunction alleged to one arm drive, clothing just got tangled in it and dealer was inquiring if there is a cover or something to keep clothing from wrapping around the one arm drive.No medical intervention.Update from 02/03/2016 added by consumer affairs: the dealer confirmed clothing guards were still on the chair at the time of the incident.Tech service also confirmed the chair was shipped with clothing guards and that we use clothing guards with a one arm drive.
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Search Alerts/Recalls
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