MAUDE Adverse Event Report: AIRGAS THERAPEUTICS LLC ISPAN GAS TANK REGULATOR; REGULATOR, PRESSURE, GAS CYLINDER

Catalog Number	8065797303
Medical Device Problem Code	Gas Output Problem (1266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A customer reported that an ophthalmic regulator would not work and it was not dispensed the gas.The procedure and patient harm details were not reported.Additional information has been requested and none received till date.Additional information received that surgery was completed by using the alternative regulator.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
This investigation will serve for the second (2nd) regulator of the two (2) the customer reported.This regulator was not returned for this investigation.A check of complaints records for the second regulator could not be performed because a valid lot number was not reported.Check of confirmed complaints against this type of regulator for flow issues showed 24 complaints since the beginning of 2016.This second regulator was not returned and there was no testing performed, as a result.With no additional related information provided, the customer reported event was not confirmed.Based upon the information provided, the root cause of the (2nd) regulator could not be determined.Manufacturer will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).

• Brand Name: ISPAN GAS TANK REGULATOR
• Common Device Name: REGULATOR, PRESSURE, GAS CYLINDER
• Manufacturer (Section D): AIRGAS THERAPEUTICS LLC; 6141 easton road; p.o. box 310; plumsteadville PA 18949
• Manufacturer (Section G): AIRGAS THERAPEUTICS LLC; 6141 easton road; p.o. box 310; plumsteadville PA 18949
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 17362353
• Report Number: 2518435-2023-00021
• Device Sequence Number: 6011442
• Product Code: CAN
• UDI-Device Identifier: 00380657973033
• UDI-Public: 00380657973033
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/16/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 8065797303
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/27/2023
• Supplement Date Received by Manufacturer: 08/18/2023; 09/21/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 08/30/2023; 10/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown