MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-13 for PUMP A127 GOFLO 72204968 manufactured by Smith & Nephew, Inc..
[120395461]
Patient Sequence No: 1, Text Type: N, H10
[120395462]
It was reported that during rotation cuff repair, pump was set at 30mmhg but shoulder became very distended and hard. Doctor feels pump pressure was greater than 30mmhg. Pump and tubing were exchanged. There was no significant delay or patient injuries.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003604053-2018-00145 |
| MDR Report Key | 7873859 |
| Date Received | 2018-09-13 |
| Date of Report | 2018-12-03 |
| Date of Event | 2018-08-30 |
| Date Mfgr Received | 2018-11-30 |
| Date Added to Maude | 2018-09-13 |
| 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 | JIM GONZALES |
| Manufacturer Street | 7000 WEST WILLIAM CANNON DRIVE |
| Manufacturer City | AUSTIN TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal | 78735 |
| Manufacturer Phone | 5123585706 |
| Manufacturer G1 | SMITH & NEPHEW, INC. |
| Manufacturer Street | 150 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01810 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PUMP A127 GOFLO |
| Generic Name | PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE |
| Product Code | FEQ |
| Date Received | 2018-09-13 |
| Returned To Mfg | 2018-09-25 |
| Catalog Number | 72204968 |
| Lot Number | 72204968 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 150 MINUTEMAN ROAD ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-13 |