ISPAN GAS TANK REGULATOR 8065797303

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-06 for ISPAN GAS TANK REGULATOR 8065797303 manufactured by Air Liquide.

Event Text Entries

[116550371] A sample is available that has not yet been received at 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


[116550372] A biomedical engineer reported that an ophthalmic gas dispensing regulator valve had no gas output prior to surgery. There was no patient involvement thus, no patient impact. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1610287-2018-00029
MDR Report Key7754731
Date Received2018-08-06
Date of Report2018-10-23
Date of Event2018-07-13
Date Mfgr Received2018-10-09
Device Manufacturer Date2017-12-11
Date Added to Maude2018-08-06
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 ContactMR. BRYAN BLAKE
Manufacturer Street6201 SOUTH FREEWAY MAIL STOP AB2-6
Manufacturer CityFORT WORTH TX 76134
Manufacturer CountryUS
Manufacturer Postal76134
Manufacturer Phone8176152230
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 Report0

Device Details

Brand NameISPAN GAS TANK REGULATOR
Generic NameINTRAOCULAR GAS
Product CodeLPO
Date Received2018-08-06
Returned To Mfg2018-08-10
Model NumberNA
Catalog Number8065797303
Lot Number734504
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerAIR LIQUIDE
Manufacturer Address13140 TI BLVD. DALLAS TX 75243 US 75243


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-08-06

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