FLEXICAIR BED

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-04-27 for FLEXICAIR BED manufactured by Supports System International.

Event Text Entries

[2860] The alleged incident happened on 3/13/93 and involved a flexicair bed. Patient was found between upper end of side rails and head of bed. Patient expired on 3/15/93. We beleive a probability may exist that the medical device may have contributed tothe deathinvalid data - regarding single use labeling of device. Patient medical status prior to event: invalid data. Invalid data - regarding 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 not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: maybe. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number5147
MDR Report Key5147
Date Received1993-04-27
Date of Report1993-03-23
Date of Event1993-03-13
Date Facility Aware1993-03-13
Report Date1993-03-23
Date Reported to Mfgr1993-03-23
Date Added to Maude1993-06-29
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 NameFLEXICAIR BED
Product CodeFNK
Date Received1993-04-27
Model NumberFLEXICAIR BED
Device Availability*
Implant Flag*
Device Sequence No1
Device Event Key4849
ManufacturerSUPPORTS SYSTEM INTERNATIONAL


Patients

Patient NumberTreatmentOutcomeDate
101. Death 1993-04-27

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.