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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AIR LIQUIDE ISPAN GAS TANK REGULATOR; INTRAOCULAR GAS
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AIR LIQUIDE ISPAN GAS TANK REGULATOR; INTRAOCULAR GAS Back to Search Results
Catalog Number 8065797303
Device Problem Defective Device (2588)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/09/2018
Event Type  malfunction  
Manufacturer Narrative
No sample or lot number information 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.The manufacturer internal reference number is: (b)(4).
 
Event Description
A healthcare professional reported that an ophthalmic gas dispensing regulator valve stopped working.Procedure details, patient involvement and patient impact information is unknown.Additional information has been requested.
 
Manufacturer Narrative
Per the regulator device contract manufacturer, no sample was returned for evaluation.With no additional, related information provided, the customer reported event was not confirmed.Additionally per the supplier, confirmed complaints for this regulator for any reason, have numbered 24 complaints since the beginning of 2011.The root cause of the reported event cannot be determined conclusively.Data will continue to be monitored for evidence of adverse trending with further action taken, as appropriate.The manufacturer internal reference number is: (b)(4).
 
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Brand Name
ISPAN GAS TANK REGULATOR
Type of Device
INTRAOCULAR GAS
Manufacturer (Section D)
AIR LIQUIDE
13140 ti blvd.
dallas TX 75243
MDR Report Key8109834
MDR Text Key128740712
Report Number1610287-2018-00046
Device Sequence Number1
Product Code LPO
Combination Product (y/n)N
PMA/PMN Number
P900066
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 07/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number8065797303
Device Lot NumberASKU
Was Device Available for Evaluation? No
Date Manufacturer Received06/24/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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