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 PLY C-OMCP-VISUB (H3000) 72238 manufactured by Philips Healthcare.
[22232085]
Philips was informed that a pt died after injection of air by an injector. Information was received on (b)(6), via an external source, independent of the hospital and unrelated to philips which leads philips to the conclusion that an adverse event incident has occurred earlier at a site where our engineer, apparently, shortly after the incident occurred was requested to check the functionality of the injector connected to one of our x-ray systems.
Patient Sequence No: 1, Text Type: D, B5
[22259271]
(b)(4). When investigation is completed, a follow-up report will be sent to the fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003768277-2011-00447 |
| MDR Report Key | 2196413 |
| Report Source | 01,07 |
| Date Received | 2011-08-04 |
| Date of Report | 2011-07-05 |
| Date of Event | 2011-01-01 |
| Date Mfgr Received | 2011-07-05 |
| Date Added to Maude | 2011-08-11 |
| 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 DRIVE |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9786597936 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PLY C-OMCP-VISUB (H3000) |
| Product Code | IZF |
| Date Received | 2011-08-04 |
| Model Number | 72238 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 1. Death | 2011-08-04 |