MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2004-04-08 for NEV100 12001 manufactured by Respironics, Inc..
[15220340]
The unit was returned for preventative maintenance with no problems identified. The unit had not been serviced by respironics since 2000. During the repair eval it was discovered that the unit's audible alarm was not functioning. The display and power boards had become loose and were reseated to correct the problem. There was no pt involvement or reported harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2518422-2004-00027 |
| MDR Report Key | 548635 |
| Report Source | 00 |
| Date Received | 2004-04-08 |
| Date of Report | 2004-03-09 |
| Date of Event | 2004-03-09 |
| Date Mfgr Received | 2004-03-09 |
| Device Manufacturer Date | 1992-09-01 |
| Date Added to Maude | 2004-10-18 |
| 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 | DAVID VANELLA |
| Manufacturer Street | 1001 MURRY RIDGE LANE |
| Manufacturer City | MURRYSVILLE PA 15866 |
| Manufacturer Country | US |
| Manufacturer Postal | 15866 |
| Manufacturer Phone | 7247335866 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEV100 |
| Generic Name | NEGATIVE PRESSURE EXTERNAL VENTILATOR |
| Product Code | BYT |
| Date Received | 2004-04-08 |
| Returned To Mfg | 2004-02-10 |
| Model Number | 12001 |
| Catalog Number | 12001 |
| Lot Number | NA |
| ID Number | * |
| Operator | OTHER |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 538103 |
| Manufacturer | RESPIRONICS, INC. |
| Manufacturer Address | 1001 MURRY RIDGE LN. MURRYSVILLE PA 156688550 US |
| Baseline Brand Name | NEV100 |
| Baseline Generic Name | NEGATIVE PRESSURE EXTERNAL VENTILATOR |
| Baseline Model No | 12001 |
| Baseline Catalog No | 12001 |
| Baseline ID | NA |
| Baseline Device Family | NEV100 |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K910947 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-04-08 |