MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-08-16 for CESAR-OMCP-VISUB (HM3000) 72239 manufactured by Philips Healthcare.
[17924005]
(b)(4). The investigation showed that the field service engineer (fse) troubleshot the system and found a bad foot pedal. After replacement of the foot pedal the problem did not recur. The patient on the table was brought to another room where the case was completed.
Patient Sequence No: 1, Text Type: N, H10
[17971353]
The customer reported that x-ray is not working while patient is on the table. No error messages were shown on the monitor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003768277-2011-00503 |
| MDR Report Key | 2239208 |
| Report Source | 07 |
| Date Received | 2011-08-16 |
| Date of Report | 2011-07-21 |
| Date Mfgr Received | 2011-07-21 |
| Date Added to Maude | 2011-10-20 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | DOMINIC SIEWKO, CHP, CNMT |
| Manufacturer Street | 3000 MINUTEMAN RD. |
| Manufacturer City | ANDOVER MA 018101099 |
| Manufacturer Country | US |
| Manufacturer Postal | 018101099 |
| Manufacturer Phone | 9786597936 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CESAR-OMCP-VISUB (HM3000) |
| Product Code | IZF |
| Date Received | 2011-08-16 |
| Model Number | 72239 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| 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 | 2011-08-16 |