MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1997-09-05 for NPB N-7500 N7500 NA manufactured by Nellcor Puritan Bennett.
[20467770]
On august 6, 1997, a nellcor puritan bennett ("npb") service technician, while performing service activities, discovered that the speaker on a n7500 central monitoring station was inoperable. This had not been reported to npb by the user facility has informed npb that there was no adverse event or pt impact associated with this device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2025525-1997-00023 |
| MDR Report Key | 118604 |
| Report Source | 07 |
| Date Received | 1997-09-05 |
| Date of Report | 1997-09-04 |
| Report Date | 1997-09-04 |
| Date Mfgr Received | 1997-08-06 |
| Device Manufacturer Date | 1993-05-01 |
| Date Added to Maude | 1997-09-11 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NPB N-7500 |
| Generic Name | CENTRAL MONITORING STATION |
| Product Code | GYE |
| Date Received | 1997-09-05 |
| Returned To Mfg | 1997-08-04 |
| Model Number | N7500 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 116298 |
| Manufacturer | NELLCOR PURITAN BENNETT |
| Manufacturer Address | 2200 FARADAY AVENUE CARLSBAD CA 92008 US |
| Baseline Brand Name | OXINET |
| Baseline Generic Name | CENTRAL MONITORING SYSTEM |
| Baseline Model No | N7500 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | MONITOR |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K952316 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-09-05 |