MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2008-05-16 for manufactured by .
[8083487]
The sd20 is comprised of a headbox unit (cat# d. 2120) and amplifier unit (cat# d. 2118). This is then integrated with other components by nellcor/covidien to create a complete sleep diagnostic system. Eb neuro is the mfr of the sd20, which is believed to be the source of the event. An investigation of the device is underway. When the investigation is complete, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9617286-2008-00001 |
| MDR Report Key | 1051500 |
| Report Source | 05,06,07 |
| Date Received | 2008-05-16 |
| Date Mfgr Received | 2008-04-16 |
| Device Manufacturer Date | 2005-04-01 |
| Date Added to Maude | 2008-05-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | AMDREA CHECCHI |
| Manufacturer Street | VIA PIETRO FANFANI, 97/A |
| Manufacturer City | FIRENZE 50127 |
| Manufacturer Country | IT |
| Manufacturer Postal | 50127 |
| Manufacturer Phone | ** |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Product Code | GWL |
| Date Received | 2008-05-16 |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 1019852 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-05-16 |