MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-23 for INTEGRIS CV (CESAR-POWERPACK-VISUB-NICOL) 722030 manufactured by Philips Healthcare.
[124984663]
When the investigation has been completed phillips will inform the fda.
Patient Sequence No: 1, Text Type: N, H10
[124984664]
Philips has received through (b)(6) a report submitted by a customer. In this report, the customer reported that? During a revision operation of an implantable cardioverter defibrillator (icd), no filming with the system was possible (foot switch does not work as on friday of the previous week for filming). The same problem had occurred on friday of the previous week; hospital medical technology was informed, was on site and stated that the problem had been solved. During the procedure, after 10 minutes of fluoroscopy with the icd already exposed, no fluoroscopy was possible. A complete shutdown of the system was done and then at least fluoroscopy was possible again. Significant delay of the operation time (thus increasing risk of infection). The affected system (philips integris cv) dates from 1996 and is in end-of-service status. As a result, the manufacturer can no longer guarantee the availability of spare parts. So far, however, all malfunctions could still be repaired. According to the original reinvestment planning, the device was to be replaced this year as part of the ppp conversions. Due to the delays in construction that have occurred in the meantime, the device is currently still in operation. From our point of view, the device should not and can no longer be operated?. Because of the allegation on potential harm this report is being submitted. Philips has initiated an investigation of this complaint.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003768277-2018-00080 |
| MDR Report Key | 7995600 |
| Date Received | 2018-10-23 |
| Date of Report | 2018-09-25 |
| Date Mfgr Received | 2018-09-25 |
| Device Manufacturer Date | 2005-05-02 |
| Date Added to Maude | 2018-10-23 |
| 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 CV (CESAR-POWERPACK-VISUB-NICOL) |
| Generic Name | SYSTEM, X-RAY, ANGIOGRAPHIC |
| Product Code | IZI |
| Date Received | 2018-10-23 |
| Model Number | 722030 |
| Catalog Number | 722030 |
| 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 | 2018-10-23 |