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 2016-01-07 for ALLURA XPER FD20 OR TABLE 722035 manufactured by Philips Healthcare.
[35258444]
The investigation is still ongoing on this event. When the investigation is completed a follow-up will sent to the fda. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[35258445]
Philips received a complaint from the customer that during a cardiac case that had 62 minutes of fluoro and 31 runs, the patient received approximately 9gy of dose.
Patient Sequence No: 1, Text Type: D, B5
[45288586]
Philips investigated this issue and reviewed the log files which showed the customer performed a tube yield calibration on the system. The tube yield calibration was done incorrectly, most likely the manually submitted parameters were entered 10 times too high. The consequences of the wrongfully executed calibration were: the dose values that the system reports (air kerma and dap) were 10 times higher than they are in reality. The system restricts the dose with fluoro, resulting in a iq reduction during fluoro. This means the reported 9 gy was not correct, the patient only received 0,9 gy. The incorrect tube yield calibration did not result in extra dose for the patients we advise the customer to follow the aiat procedure when calibrating the x-ray tube to prevent the issue from occurring again. This aiat procedure is to be found on philips incenter which is available for the customer. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003768277-2016-00005 |
| MDR Report Key | 5350966 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-01-07 |
| Date of Report | 2015-12-11 |
| Date of Event | 2015-12-01 |
| Date Mfgr Received | 2015-12-11 |
| Device Manufacturer Date | 2015-06-25 |
| Date Added to Maude | 2016-01-07 |
| 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 | OWB |
| Date Received | 2016-01-07 |
| Model Number | 722035 |
| Catalog Number | 722035 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2016-01-07 |
| Model Number | 722035 |
| Catalog Number | 722035 |
| 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 | 1. Other | 2016-01-07 |