MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-02 for ARROW VASCULAR POSITIONING SYSTEM VPS-G4C manufactured by Arrow International Inc..
[181974281]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[181974282]
The customer reported that their machine is not correlating to the cxr.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003898360-2020-00227 |
| MDR Report Key | 9775949 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-02 |
| Date of Report | 2020-02-18 |
| Date of Event | 2020-02-18 |
| Date Mfgr Received | 2020-02-18 |
| Device Manufacturer Date | 2015-01-27 |
| Date Added to Maude | 2020-03-02 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MARGIE BURTON, RN |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334965 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | RANCHO EL DESCANSO |
| Manufacturer City | TECATE 21478 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 21478 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARROW VASCULAR POSITIONING SYSTEM |
| Generic Name | CATHETER ULTRASOUND VASCULAR |
| Product Code | OBJ |
| Date Received | 2020-03-02 |
| Returned To Mfg | 2020-02-28 |
| Catalog Number | VPS-G4C |
| Lot Number | 19F15A0033 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARROW INTERNATIONAL INC. |
| Manufacturer Address | READING PA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-02 |