MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-12-15 for DIAGNOST 76PLUS 70639 NA manufactured by Philips Medical Systems.
[16113245]
The customer reported that a metal band on the system's cassette tray had come loose and was allegedly hanging in the vicinity of the pt. The customer also reported the system was still fully functional.
Patient Sequence No: 1, Text Type: D, B5
[16332243]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003768251-2010-00068 |
| MDR Report Key | 1942678 |
| Report Source | 05 |
| Date Received | 2010-12-15 |
| Date of Report | 2010-11-16 |
| Date of Event | 2010-11-16 |
| Date Mfgr Received | 2010-11-16 |
| Date Added to Maude | 2011-06-06 |
| 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 | CHAE CHANG |
| Manufacturer Street | 22100 BOTHELL EVERETT HWY |
| Manufacturer City | BOTHELL WA 98041 |
| Manufacturer Country | US |
| Manufacturer Postal | 98041 |
| Manufacturer Phone | 4259082109 |
| Manufacturer G1 | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Street | ROENTGENSTRASSE 24 |
| Manufacturer City | HAMBURG 22335 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 22335 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIAGNOST 76PLUS |
| Product Code | IXL |
| Date Received | 2010-12-15 |
| Model Number | 70639 |
| Catalog Number | NA |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | ROENTGENSTRASSE 24 HAMBURG 22335 GM 22335 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-12-15 |