* BC31 TB2

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-07-27 for * BC31 TB2 manufactured by Pisces Productions Inc.

Event Text Entries

[362925] Patient sitting at edge of portable recliner bed in mobile blood bank facility. Bed did not hold and collapsed. The safety pin did not hold.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number545045
MDR Report Key545045
Date Received2004-07-27
Date of Report2004-07-27
Date of Event2004-06-08
Report Date2004-07-27
Date Reported to FDA2004-07-27
Date Added to Maude2004-09-23
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 Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand Name*
Generic NamePORTABLE RECLINER BED
Product CodeFML
Date Received2004-07-27
Model NumberBC31 TB2
Catalog Number*
Lot Number*
ID Number*
Device AvailabilityY
Device Age1.5 YR
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key534453
ManufacturerPISCES PRODUCTIONS INC
Manufacturer Address380 A MORRIS ST. SEBASTOPOL CA 95427 US


Patients

Patient NumberTreatmentOutcomeDate
10 2004-07-27

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