MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-25 for INTEGRIS ALLURA 9 BIPLANE 722021 manufactured by Philips Healthcare.
[121718774]
When the investigation has been completed philips will inform the fda.
Patient Sequence No: 1, Text Type: N, H10
[121718775]
It has been reported to philips that during a procedure on a newborn patient the system spontaneously stopped working. The patient was transferred to another room where the procedure was completed. To date philips has not received further information about the condition of the patient. An investigation of the reported issue has been initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003768277-2018-00073 |
| MDR Report Key | 7905449 |
| Date Received | 2018-09-25 |
| Date of Report | 2018-09-04 |
| Date Mfgr Received | 2018-09-04 |
| Device Manufacturer Date | 2003-02-04 |
| Date Added to Maude | 2018-09-25 |
| 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 | MR. DUSTY LEPPERT |
| Manufacturer Street | VEENPLUIS 4-6 P.O. BOX 10.000 |
| Manufacturer City | BEST 5680DA |
| Manufacturer Country | NL |
| Manufacturer Postal | 5680 DA |
| Manufacturer G1 | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Street | 3000 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 | INTEGRIS ALLURA 9 BIPLANE |
| Generic Name | INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM |
| Product Code | IZI |
| Date Received | 2018-09-25 |
| Model Number | 722021 |
| Catalog Number | 722021 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS HEALTHCARE |
| Manufacturer Address | VEENPLUIS 4-6 P.O. BOX 10.000 BEST 5680DA NL 5680 DA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-25 |