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 2015-10-28 for ALLURA XPER FD20 OR TABLE 722035 manufactured by Philips Healthcare.
[29778104]
The investigation is still ongoing on this event. When the investigation is completed a follow-up will sent to the fda contact office address (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[29778105]
Philips received a complaint from the customer in which they stated that a patient was harmed due to receiving a higher dose than necessary. Philips is in the process of acquiring more detailed information from the customer.
Patient Sequence No: 1, Text Type: D, B5
[37187378]
A philips service engineer went on site but was unable to obtain log files to troubleshoot the issue. Due to the nature of the error no dose report was available, but the customer confirmed that there was no harm to the patient the philips service engineer was unable to replicate the reported issue on the system and could not find anything out of the ordinary. Since we could not replicate the issue and no log files are available, we see this issue as a one time occurrence. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003768277-2015-00092 |
| MDR Report Key | 5185063 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2015-10-28 |
| Date of Report | 2015-09-29 |
| Date of Event | 2015-09-01 |
| Date Mfgr Received | 2015-09-29 |
| Date Added to Maude | 2015-10-28 |
| 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 |
| 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 | OWB |
| Date Received | 2015-10-28 |
| Model Number | 722035 |
| Catalog Number | 722035 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS HEALTHCARE |
| Manufacturer Address | VEENPLUIS 4-6 P.O. BOX 10.000 BEST 5680DA NL 5680 DA |
| Brand Name | ALLURA XPER FD20 OR TABLE |
| Generic Name | ANGIOGRAPHIC X-RAY SYSTEM, SOLID X-RAY IMAGER |
| Product Code | OBW |
| Date Received | 2015-10-28 |
| Model Number | 722035 |
| Catalog Number | 722035 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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. Other | 2015-10-28 |