ISPAN GAS TANK REGULATOR 8065797303

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-04-09 for ISPAN GAS TANK REGULATOR 8065797303 manufactured by Air Liquide.

Event Text Entries

[141352634] No sample has been received by manufacturing for evaluation. Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available. Additional information has been requested. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[141352635] A healthcare professional reported that an ophthalmic gas dispensing regulator was used during multiple vitrectomy surgeries which consistently showed 100psi pressure on the gauge. Some patient eyes had to be subsequently topped off with additional gas. Additional information has been requested. Additional information received clarified that the ophthalmic gas delivered through the suspect regulator was used at varying concentrations. The gas concentration was mixed with unspecified amounts of filtered air.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1610287-2019-00007
MDR Report Key8495967
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2019-04-09
Date of Report2019-10-07
Date Mfgr Received2019-09-24
Device Manufacturer Date2017-08-09
Date Added to Maude2019-04-09
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
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
Manufacturer ContactMS. CINDY MILAM
Manufacturer Street6201 SOUTH FREEWAY MAIL STOP AB2-6
Manufacturer CityFORT WORTH TX 76134
Manufacturer CountryUS
Manufacturer Postal76134
Manufacturer Phone8176152231
Manufacturer G1AIR LIQUIDE
Manufacturer Street13140 TI BLVD.
Manufacturer CityDALLAS TX 75243
Manufacturer CountryUS
Manufacturer Postal Code75243
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameISPAN GAS TANK REGULATOR
Generic NameINTRAOCULAR GAS
Product CodeLPO
Date Received2019-04-09
Model NumberNA
Catalog Number8065797303
Lot Number722120
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerAIR LIQUIDE
Manufacturer Address13140 TI BLVD. DALLAS TX 75243 US 75243


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-04-09

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