MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2006-12-21 for NEV 100 12001 manufactured by Respironics, Inc..
[542230]
Info was received that the device allegedly shut down and sounded a beeping alarm while in pt use. The pt was found to be non-responsive by the caregiver, who called 911 and the pt was transferred to a hosp where he later expired. Allegedly, the audible alarm was not heard by the caregiver. The duration between when the device allegedly shut down and when the caregiver attended to the pt is unk. An autopsy was performed, but the results were not released upon request. Although ventilator dependent, the pt used the device in a non-invasive manner only at night. Another device was used throughout the day. It is unk if add'l alarms were in use at the time of the event. The device is in the possesssion of the county coroner and a request to have the device returned to the mfr for eval was denied. The device will be evaluated by an independent third party. If pertinent info becomes available, a follow-up report will be filed.
Patient Sequence No: 1, Text Type: D, B5
[8058879]
H6: the device is quarantined by the coroner. A request to have the device returned to the mfr for eval was denied. The device will be evaluated by an independent third party. H6: no eval has been performed at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2518422-2006-00108 |
| MDR Report Key | 797681 |
| Report Source | 00 |
| Date Received | 2006-12-21 |
| Date of Report | 2006-11-30 |
| Date of Event | 2006-11-22 |
| Date Mfgr Received | 2006-11-30 |
| Device Manufacturer Date | 1999-09-01 |
| Date Added to Maude | 2006-12-26 |
| 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 | KATHY DE PADUA |
| Manufacturer Street | 1001 MURRY RIDGE LANE |
| Manufacturer City | MURRYSVILLE PA 15668 |
| Manufacturer Country | US |
| Manufacturer Postal | 15668 |
| Manufacturer Phone | 7243877770 |
| 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 | NEV 100 |
| Generic Name | EXTERNAL NEGATIVE PRESSURE VENTILATOR |
| Product Code | BYT |
| Date Received | 2006-12-21 |
| Model Number | 12001 |
| Catalog Number | 12001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 785214 |
| 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. Death | 2006-12-21 |