POSEY WHEELCHAIR BELT, LAP BELT WITH SLIDE BUCKLES 4130

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-06-23 for POSEY WHEELCHAIR BELT, LAP BELT WITH SLIDE BUCKLES 4130 manufactured by J.t. Posey Co..

Event Text Entries

[18832251] Resident diagnoses:cerebrallar ataxia; osteoporosis, anemia, hyperacidity, sundown syndrome, dementia, history of depression, arterial fibrillation, history of syncope. At 7:50 p. M. Nurse aide checked resident and found her to be positioned properly in wheelchair. Feet were on the foot pedals, resident sitting up straight and the gray belt restraint properly applied. Approximately 8:05-8:10 p. M. , the rn entered resident's room to check her epilock dressing. Rn found resident unresponsive without pulse or respiration, seated forward in her wheelchair with her arms extended above her head; the gray belt restraint was under her arms and tight across her upper chest. Resident had a do not resuscitate order. Resident had a physician's order for a safety belet in wheelchair at all times with a back release belet. Medical examiner called and came to investigate death. Medical examiner took body for autopsy along with resident's glasses, dentures, key, watch, wheelchair, cushions, restraint and pillowinvalid data - regarding single use labeling of device. Patient medical status prior to event: unknown. 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: none or unknown. Results of evaluation: none or unknown. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: other. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number791
MDR Report Key791
Date Received1992-06-23
Date of Report1992-06-16
Date of Event1992-06-04
Date Facility Aware1992-06-04
Report Date1992-06-16
Date Reported to FDA1992-06-16
Date Reported to Mfgr1992-06-05
Date Added to Maude1992-06-29
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 NamePOSEY WHEELCHAIR BELT, LAP BELT WITH SLIDE BUCKLES
Product CodeKNO
Date Received1992-06-23
Model Number4130
Catalog Number4130
ID NumberN/A
OperatorOTHER HEALTH CARE PROFESSIONAL
Device AvailabilityN
Implant FlagN
Device Sequence No1
Device Event Key769
ManufacturerJ.T. POSEY CO.


Patients

Patient NumberTreatmentOutcomeDate
101. Death 1992-06-23

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