UNKNOWN 6083 N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-08 for UNKNOWN 6083 N/A manufactured by Pcp Champion Division Of Surgical Appl. Ind., Inc..

Event Text Entries

[20994535] Lpn entered resedent's room at 6:00a. M. On 11/26/91 and found resident on floor with ehr hed between the siderail and mattress. The resident was facing towards the window, head pointing down, chion to chest, sitting on feet as if in a kneeling position. Her left hand was holding onto the siderail. Her right side was leaning against the bed. Patient had no pulse or respiration. Rn called the medical examiner to inform him of the situation. The medical examiner arrived at 9:45 a. M. With an assistant. The patient's body was remoiv ed by he medial examiner to determine ifc a post mortem was needed to be performed. Via a phone conservation, the medical examiner relayed to the director of nursing that the death was possibly accidental, due to asphixation by equipment failure. Important information to note: resident not restrained in bed, 1/2 length bedrails were in usedevice labeled for single use. Patient medical status prior to event: critical condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3907
MDR Report Key3907
Date Received1992-07-08
Date of Event1991-11-26
Date Facility Aware1991-11-26
Date Reported to Mfgr1991-11-27
Date Added to Maude1993-05-07
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameUNKNOWN
Generic NameSHORT BEDRAIL
Product CodeFNK
Date Received1992-07-08
Model Number6083
Catalog NumberN/A
Lot NumberN/A
ID NumberN/A
Device Availability*
Implant FlagN
Device Sequence No1
Device Event Key3647
ManufacturerPCP CHAMPION DIVISION OF SURGICAL APPL. IND., INC.


Patients

Patient NumberTreatmentOutcomeDate
101. Death 1992-07-08

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