MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-02 for ISPAN GAS TANK REGULATOR 8065797303 manufactured by Air Liquide.
[113173125]
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
[113173126]
A customer reported that an ophthalmic gas dispensing regulator valve was clogged. Procedure details, patient involvement and patient impact information is unknown. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
[120873912]
Corrected information is provided in section to code that no sample had been received for evaluation at the time of the initial report. The customer reported that their regulator device did not deliver gas. No additional product information has been obtained to date. With no additional, related information provided, the customers reported event was not able to be confirmed. The root cause cannot be determined conclusively. Data will continue to be monitored for evidence of adverse trending with further action taken, as appropriate. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1610287-2018-00023 |
| MDR Report Key | 7654611 |
| Date Received | 2018-07-02 |
| Date of Report | 2018-09-20 |
| Date Mfgr Received | 2018-09-07 |
| Device Manufacturer Date | 2009-01-08 |
| Date Added to Maude | 2018-07-02 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. BRYAN BLAKE |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8176152230 |
| 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 | 0 |
| Brand Name | ISPAN GAS TANK REGULATOR |
| Generic Name | INTRAOCULAR GAS |
| Product Code | LPO |
| Date Received | 2018-07-02 |
| Model Number | NA |
| Catalog Number | 8065797303 |
| Lot Number | 900802 |
| 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 | 2018-07-02 |