inforMED
MalfunctionOGH

RUSCH MRI COND FIBER OPTIC LARYN KIT

Received Jul 1, 2015 · Event occurred Jun 18, 2014

Report 1044475-2015-00216 · MDR key 4884497

Device

Generic name

Mri Laryngoscope Kit

Manufacturer

Teleflex Medical

Catalog number

005852300

Lot number

132601

Product problems

  • Inadequate Lighting
  • Optical Problem

Patient

Not reported

  • No Consequences Or Impact To Patient

Narrative

Additional Manufacturer Narrative

(B)(4). THE SAMPLE WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED. IF THE SAMPLE IS RETURNED, A FOLLOW-UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS.

Description of Event or Problem

THE CUSTOMER ALLEGES THAT THE LIGHT BUNDLE WILL NOT LIGHT ON THE MAC 2 BLADE. INTUBATION WAS ACCOMPLISHED WITH A STANDARD LARYNGOSCOPE SET. NO PATIENT INJURY REPORTED.

Additional Manufacturer Narrative

(B)(4). THE DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT.

Description of Event or Problem

THE CUSTOMER ALLEGES THAT THE LIGHT BUNDLE WILL NOT LIGHT ON THE MAC 2 BLADE. INTUBATION WAS ACCOMPLISHED WITH A STANDARD LARYNGOSCOPE SET. NO PATIENT INJURY REPORTED.