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 2019-03-20 for ALLURA XPER FD20 OR TABLE 722035 manufactured by Philips Healthcare.
[139298929]
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Patient Sequence No: 1, Text Type: N, H10
[139298930]
It has been reported to philips that during a procedure the cover of the l-arm of the allura system got detached when the l-arm collided with the arm of the operating light. The cover was held by a chain and did not fall. When the cover detached, dust came out and fell on the operating field. Philips has been reported that the patient stayed at the hospital 5 days instead of 24 hours to get a preventive treatment with antibiotics. The patient was doing well and no patient harm has been reported to philips. Philips has initiated an investigation of this complaint.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003768277-2019-00022 |
| MDR Report Key | 8435618 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-03-20 |
| Date of Report | 2019-02-22 |
| Date of Event | 2019-02-22 |
| Date Mfgr Received | 2019-03-11 |
| Device Manufacturer Date | 2015-11-26 |
| Date Added to Maude | 2019-03-20 |
| 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 | 3 |
| Brand Name | ALLURA XPER FD20 OR TABLE |
| Generic Name | ANGIOGRAPHIC X-RAY SYSTEM, SOLID X-RAY IMAGER |
| Product Code | JAA |
| Date Received | 2019-03-20 |
| Model Number | 722035 |
| Catalog Number | 722035 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| 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 | 1. Hospitalization | 2019-03-20 |