ENDURO OPTIMA TILT IN SPACE WHEELCHAIR N/I

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-11-20 for ENDURO OPTIMA TILT IN SPACE WHEELCHAIR N/I manufactured by Loyal La-plante Supply Company.

Event Text Entries

[1274] On 11/4/92, client was placed in her wheelchair at approximately 6:20 a. M. This is a special made wheelchair for this clients needs, as recommended by the physical therapist and her physician. At approximately 6:40 a. M. , the staff on duty found this client in her wheelchair, but had slipped down in the chair and the buterfly breast plate attached to this chair for proper support and alignment, was under the client's neck. She was immediately removed from the chair and cpr and emergency procedures administered without respone from the client. The staff followed all procedures and directives as they had in the past in applying this breast plate. The body was sent to the medical examiner's office, as requested by the physician and they reported back to this facility that the cause of death was positional asphyxiation. This was reported to the state health department and all other agencies concerneddevice labeled for single use. Patient medical status prior to event: satisfactory 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. Device was evaluated after the event. Method of evaluation: performance tests performed, visual examination. Results of evaluation: none or unknown. Conclusion: there was no device failure. Certainty of device as cause of or contributor to event: yes. Corrective actions: inserviced by other facility staff. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1865
MDR Report Key1865
Date Received1992-11-20
Date of Report1992-11-18
Date of Event1992-11-04
Date Facility Aware1992-11-04
Report Date1992-11-18
Date Reported to FDA1992-11-18
Date Reported to Mfgr1992-11-17
Date Added to Maude1992-12-09
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 NameENDURO OPTIMA TILT IN SPACE WHEELCHAIR
Generic NameBUTTERFLY BREAST PLATE - ATTACHED BY STRAPS TO WHEELCHAIR
Product CodeKID
Date Received1992-11-20
Model NumberN/I
Catalog NumberN/I
Lot NumberN/I
ID NumberN/I
Device AvailabilityY
Device Age01-AUG-90
Implant FlagN
Device Sequence No1
Device Event Key1741
ManufacturerLOYAL LA-PLANTE SUPPLY COMPANY


Patients

Patient NumberTreatmentOutcomeDate
101. Death 1992-11-20

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