9400 STROBE LIGHT UNIT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-16 for 9400 STROBE LIGHT UNIT manufactured by Pentax Of America, Inc..

Event Text Entries

[175669408] The 9400 strobe light unit developed corrosion of the halogen light bulb, causing the halogen bulb to fail before its expected life span. This has occurred on 4 occasions and the halogen bulbs have all failed before 10 hrs of use. Unit sn (b)(4). Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5092317
MDR Report Key9601345
Date Received2020-01-16
Date of Report2020-01-15
Date of Event2019-01-09
Date Added to Maude2020-01-17
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name9400 STROBE LIGHT UNIT
Generic NameLARYNGOSTROBOSCOPE
Product CodeEQL
Date Received2020-01-16
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerPENTAX OF AMERICA, INC.
Manufacturer AddressMONTVALE NJ 07645 US 07645


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-16

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