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.
[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
| Report Number | 1610287-2019-00007 |
| MDR Report Key | 8495967 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-04-09 |
| Date of Report | 2019-10-07 |
| Date Mfgr Received | 2019-09-24 |
| Device Manufacturer Date | 2017-08-09 |
| Date Added to Maude | 2019-04-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CINDY MILAM |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8176152231 |
| Manufacturer G1 | AIR LIQUIDE |
| Manufacturer Street | 13140 TI BLVD. |
| Manufacturer City | DALLAS TX 75243 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75243 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ISPAN GAS TANK REGULATOR |
| Generic Name | INTRAOCULAR GAS |
| Product Code | LPO |
| Date Received | 2019-04-09 |
| Model Number | NA |
| Catalog Number | 8065797303 |
| Lot Number | 722120 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AIR LIQUIDE |
| Manufacturer Address | 13140 TI BLVD. DALLAS TX 75243 US 75243 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-09 |