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OtherCBH

B7048 - TUBE RESTRAINT

Received Sep 25, 2001 · Event occurred Feb 17, 1995

Report 1647162-2001-00001 · MDR key 354274

Device

Generic name

Endotracheal Tube Securing Device

Manufacturer

Ergomed, Inc.

Model number

B7048

Catalog number

B7048-TUBE RESTRAINT

Lot number

*

Product problems

  • Loose
  • Use of Device Problem

Patient

UNKNOWN

  • Unknown (for use when the patient's condition is not known)

Narrative

Description of Event or Problem

COMPLAINT WAS DUE TO DEVICE B7048. TUBE RESTRAINT WAS NOT SECURING INTUBATED TUBE. FOLLOW UP IN 3/95 PHONECALL THAT USING UNIT WAS NOT APPLYING DEVICE PROPERLY. PER INSTRUCTIONS WRITTEN ON BAG. DIRECTOR OF EMS UNIT REPORTED THAT PROBLEM WAS SOLVED THROUGH PROPER APPLICATION INSTRUCTION.

Remedial action

  • Other