MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2005-12-09 for NELLCOR N400 manufactured by Plymouth.
[413437]
In 2005, nellcor puritan bennett received a report where it was claimed that a patient experienced a personal injury while a n400 fetal pulse oximeter was in use. The report did not specify what type of personal injury the patient experienced.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2936999-2005-00525 |
| MDR Report Key | 650969 |
| Report Source | 00 |
| Date Received | 2005-12-09 |
| Date of Report | 2005-11-18 |
| Date of Event | 2005-03-17 |
| Date Mfgr Received | 2005-11-18 |
| Date Added to Maude | 2005-12-12 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | RENEE SAAVENDRA, ANALYST |
| Manufacturer Street | * |
| Manufacturer City | PLEASANTON CA 94588 |
| Manufacturer Country | US |
| Manufacturer Postal | 94588 |
| Manufacturer Phone | 9254634472 |
| Manufacturer G1 | PLYMOUTH |
| Manufacturer Street | 2800 NORTHEAST BLVD. |
| Manufacturer City | PLYMOUTH MN 55441 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55441 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NELLCOR |
| Generic Name | FETAL OXYGEN SAT MONITOR |
| Product Code | MMA |
| Date Received | 2005-12-09 |
| Model Number | N400 |
| Catalog Number | N400 |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 640443 |
| Manufacturer | PLYMOUTH |
| Manufacturer Address | 2800 NORTHWEST BLVD. PLYMOUTH MN 55441 US |
| Baseline Brand Name | NELLCOR |
| Baseline Generic Name | FETAL OXYGEN SAT MONITOR |
| Baseline Model No | N400 |
| Baseline Catalog No | N400 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-12-09 |