MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2011-08-04 for POLY C-OMCP-VISUB (H3000) 72238 manufactured by Philips Healthcare.
[1998984]
The customer reported that during operation an error occurred stating "that frontal generator was not available. "
Patient Sequence No: 1, Text Type: D, B5
[9148424]
(b)(4). The field service engineer (fse) troubleshot the system and found a problem there was an intermittent error in the communication between the generator and the tube. He replaced the printed circuit board (serial data link) responsible for communication between generator and tube, this solved the problem. The system was last produced in 1998, and was declared end of life as of 2010.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003768277-2011-00482 |
| MDR Report Key | 2199674 |
| Report Source | 01,07 |
| Date Received | 2011-08-04 |
| Date of Report | 2011-07-06 |
| Date Mfgr Received | 2011-07-06 |
| Date Added to Maude | 2011-09-23 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | DOMINIC SIEWKO |
| Manufacturer Street | 3000 MINUTEMAN DR. |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9786597936 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POLY C-OMCP-VISUB (H3000) |
| Product Code | IZF |
| Date Received | 2011-08-04 |
| Model Number | 72238 |
| 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 BEST 5680DA NL 5680 DA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-08-04 |