MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1997-05-14 for NELLCOR PURITAN BENNETT N7500 NA manufactured by Puritan-bennett Corp..
[61501]
User reports that central monitoring station's audible alarm volume was too low to hear. A caregiver heard the bedside monitor alarm as they walked by the pt's room. User reports there was a delay in responding to the pt's acute desaturation into the 80% range, and that some ventilator adjustments were made although the extent of changes is unknown at this time. The pt reportedly suffered no injury or impairment as a result of the alleged incident. It is not verified that the alarm volume was too low and no malfunction may have occurred. This report is not an admission by nellcor puritan bennett that this device caused or contributed to the event alleged in this report.
Patient Sequence No: 1, Text Type: D, B5
[7762134]
The n7500 central monitoring station was returned to npb for evaluation. The alarms were found to be operating appropriately. The customer's report could not be duplicated. Npb has informed the hospital of co's findings. Npb considers the matter to be closed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2025525-1997-00006 |
| MDR Report Key | 92370 |
| Report Source | 05,06 |
| Date Received | 1997-05-14 |
| Report Date | 1997-04-15 |
| Date Mfgr Received | 1997-04-15 |
| Device Manufacturer Date | 1991-11-01 |
| Date Added to Maude | 1997-05-23 |
| 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 |
| Reporter Occupation | RESPIRATORY THERAPIST |
| 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 | NELLCOR PURITAN BENNETT |
| Generic Name | CENTRAL MONITORING SYSTEM |
| Product Code | GYE |
| Date Received | 1997-05-14 |
| Model Number | N7500 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 6 YR |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 91237 |
| Manufacturer | PURITAN-BENNETT CORP. |
| Manufacturer Address | 2200 FARADAY AVE. 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 | 1997-05-14 |