MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2000-05-05 for SERVICE REP, C/U, INTELIJET, 120V 4350H manufactured by Smith & Nephew, Inc.-endoscopy Div.
[150892]
Approximately halfway through the shoulder surgery the pump began to pump at a high rate. The hosp has had problems in the past with pumps overpressurizing and immediately shut the pump off. The pt's shoulder was opened to complete the surgery. The surgery was completed and there were no reported injuries or complications as a result of the pump overpressurizing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1643264-2000-00020 |
| MDR Report Key | 276864 |
| Report Source | 05,06 |
| Date Received | 2000-05-05 |
| Date of Report | 2000-05-04 |
| Date of Event | 2000-04-05 |
| Date Mfgr Received | 2000-04-19 |
| Date Added to Maude | 2000-05-11 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | STEVE JACKSON |
| Manufacturer Street | 3600 NW 138TH |
| Manufacturer City | OKLAHOMA CITY OK 73134 |
| Manufacturer Country | US |
| Manufacturer Postal | 73134 |
| Manufacturer Phone | 4059363000 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SERVICE REP, C/U, INTELIJET, 120V |
| Generic Name | ARTHROSCOPIC IRRIGATION PUMP |
| Product Code | HRT |
| Date Received | 2000-05-05 |
| Returned To Mfg | 2000-04-19 |
| Model Number | 4350H |
| Catalog Number | 4350H |
| Lot Number | * |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 267988 |
| Manufacturer | SMITH & NEPHEW, INC.-ENDOSCOPY DIV |
| Manufacturer Address | 160 DASCOMB RD ANDOVER MA 01810 US |
| Baseline Brand Name | SERVICE REP, C/U, INTELIJET, 120V |
| Baseline Generic Name | ARTHROSCOPIC IRRIGATION PUMP |
| Baseline Model No | 4350H |
| Baseline Catalog No | 4350H |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-05-05 |