MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2001-07-20 for NEV-100 12001 manufactured by Respironics, Inc..
[17807655]
Report received from distributor that a patient had expired after a power outage occurred at their place of residence. Information obtained from respiratory therapist is as follows: the pt resided at an assisted care facility which had suffered from a power outage on event date around 11:30pm. The patient was using the device at that time. The power outage caused the unit to shut down and sound an alarm, just as intended. The pt reportedly refused to exit the nu-mo suit and wanted to wait till power returned. Approximately 10-15 minutes had passed, the power returned but the electrical outlets reportedly would not work. The nurse left the room to notify the manager and, in the meantime, the patient's spouse reported pt stopped breathing. Cpr was initiated without success. There were no alleged complaints with the device and respiratory therapist felt the device responded appropriately. The pt reportedly suffered from a massive heart attack. Per the manager at the distributor, the pt did not use the device continuously.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2518422-2001-00036 |
| MDR Report Key | 343086 |
| Report Source | 05,08 |
| Date Received | 2001-07-20 |
| Date of Report | 2001-06-21 |
| Date of Event | 2001-06-15 |
| Date Facility Aware | 2001-06-21 |
| Report Date | 2001-07-20 |
| Date Mfgr Received | 2001-06-21 |
| Device Manufacturer Date | 1999-08-01 |
| Date Added to Maude | 2001-07-24 |
| 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 |
| Manufacturer Contact | CALVIN EGGERS |
| Manufacturer Street | 1001 MURRY RIDGE DRIVE |
| Manufacturer City | MURRYSVILLE PA 156688550 |
| Manufacturer Country | US |
| Manufacturer Postal | 156688550 |
| Manufacturer Phone | 7243874217 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEV-100 |
| Generic Name | NEGATIVE PRESSURE EXTERNAL VENTILATOR |
| Product Code | BYT |
| Date Received | 2001-07-20 |
| Model Number | 12001 |
| Catalog Number | 12001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 23 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 332422 |
| Manufacturer | RESPIRONICS, INC. |
| Manufacturer Address | 1001 MURRY RIDGE DR. 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 | 2001-07-20 |