MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-10 for PRESSURE MONITORING KIT WITH TRUWAVE DISPOSABLE PRESSURE TRANSDUCER PX260 manufactured by Edwards Lifesciences Dr.
[188652301]
The device evaluation is anticipated. However, the complaint cannot not be confirmed without the completion of a product evaluation. A supplemental report will be forthcoming with the evaluation results when received. A review of the manufacturing records indicated that the product met specifications upon release.
Patient Sequence No: 1, Text Type: N, H10
[188652302]
It was reported that when this dpt (disposable pressure transducer) was connected to a right femoral line of a (b)(6) female patient, the systolic and diastolic pressure values did not match with the pressure values obtained with a non-invasive bp cuff. The sensor was zeroed and calibrated, and the line was flushed. However, the values shown on the monitor were too high and were not consistent with the patient's condition. The line was flushed several more times, but the same problem was still present, so they requested another transducer with which the values were different and more accurate to the patient's condition. The device was available for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2020-10125 |
| MDR Report Key | 9576299 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-10 |
| Date of Report | 2019-12-13 |
| Date of Event | 2019-12-12 |
| Date Mfgr Received | 2019-12-24 |
| Device Manufacturer Date | 2019-09-28 |
| Date Added to Maude | 2020-01-10 |
| 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 | MRS SAMANTHA EVELEIGH |
| Manufacturer Street | 1 EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9492503939 |
| Manufacturer G1 | EDWARDS LIFESCIENCES DR |
| Manufacturer Street | PARQUE INDUSTRIAL DE ITABO CARR. SANCHEZ KM 18.5 |
| Manufacturer City | HAINA, SAN CRISTOBAL |
| Manufacturer Country | DR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRESSURE MONITORING KIT WITH TRUWAVE DISPOSABLE PRESSURE TRANSDUCER |
| Generic Name | TRANSDUCER, PRESSURE, CATHETER TIP |
| Product Code | DXO |
| Date Received | 2020-01-10 |
| Returned To Mfg | 2020-02-04 |
| Model Number | PX260 |
| Catalog Number | PX260 |
| Lot Number | 62625588 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFESCIENCES DR |
| Manufacturer Address | PARQUE INDUSTRIAL DE ITABO CARR. SANCHEZ KM 18.5 HAINA, SAN CRISTOBAL DR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-10 |