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 2017-07-24 for VAMP PLUS VP0613 manufactured by Edwards Lifesciences Dr.
[80895940]
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. Lot number was not provided, therefore review of the manufacturing records could not be completed.
Patient Sequence No: 1, Text Type: N, H10
[80895941]
It was reported that during use of this pressure monitoring set with vamp plus, high pressure values were observed. Therefore, the nurses administered medication in order to reduce the pressure. Subsequently the nurse noted that the pressures from the pressure monitoring set did not correlate with a brachial cuff pressure. There was no allegation of patient injury. To date, no additional information has been able to be obtained, including patient demographics.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2017-02191 |
| MDR Report Key | 6737165 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-07-24 |
| Date of Report | 2017-07-07 |
| Date of Event | 2017-06-26 |
| Date Mfgr Received | 2017-08-24 |
| Date Added to Maude | 2017-07-24 |
| 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 | MS LYNN SELAWSKI |
| Manufacturer Street | 1 EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9497564386 |
| 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 | VAMP PLUS |
| Generic Name | KIT, SAMPLING, ARTERIAL BLOOD |
| Product Code | CBT |
| Date Received | 2017-07-24 |
| Returned To Mfg | 2017-08-21 |
| Model Number | VP0613 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-07-24 |