MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-08-08 for NEV 100 12001 manufactured by Respironics Inc..
[116448686]
The manufacturer received information indicating a patient expired while using a negative pressure ventilator during a power outage. The manufacturer is currently investigating this event and a follow-up report will be filed when the investigation is complete.
Patient Sequence No: 1, Text Type: D, B5
[135510865]
It was initially reported the manufacturer received information indicating a patient expired while using a negative pressure ventilator during a power outage. The nev 100 ventilator was returned to the manufacturer for evaluation. When the device was powered on, it operated as designed, but was alarming. The device's timing belt required adjustment to address the alarm. No other issues where observed. The nev 100 does not have an internal battery backup in the event of a power failure. The nev 100 was supplied to the patient with a backup generator. The generator was never installed and was unavailable when the power outage occurred.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2518422-2018-01854 |
| MDR Report Key | 7763622 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-08-08 |
| Date of Report | 2019-01-08 |
| Date of Event | 2018-07-29 |
| Date Mfgr Received | 2019-01-08 |
| Device Manufacturer Date | 1998-07-01 |
| Date Added to Maude | 2018-08-08 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ADAM PRICE |
| Manufacturer Street | 312 ALVIN DRIVE |
| Manufacturer City | NEW KENSINGTON PA 15668 |
| Manufacturer Country | US |
| Manufacturer Postal | 15668 |
| Manufacturer Phone | 7243349303 |
| Manufacturer G1 | RESPIRONICS INC. |
| Manufacturer Street | 1001 MURRY RIDGE LANE |
| Manufacturer City | MURRYSVILLE PA 15668 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 15668 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEV 100 |
| Generic Name | VENTILATOR, EXTERNAL BODY, NEGATIVE PRESSURE, ADULT (CUIRASS) |
| Product Code | BYT |
| Date Received | 2018-08-08 |
| Returned To Mfg | 2018-10-11 |
| Model Number | 12001 |
| Catalog Number | 12001 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESPIRONICS INC. |
| Manufacturer Address | 1001 MURRY RIDGE LANE MURRYSVILLE PA 15668 US 15668 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2018-08-08 |