NEV 100
Received Aug 8, 2018 · Event occurred Jul 29, 2018
Report 2518422-2018-01854 · MDR key 7763622
Device
Generic name
Ventilator, External Body, Negative Pressure, Adult (cuirass)
Manufacturer
Respironics Inc.Model number
12001Catalog number
12001
Product problems
- Adverse Event Without Identified Device or Use Problem
- Insufficient Device Problem Information
- Adverse Event Without Identified Device or Use Problem
- Insufficient Device Problem Information
Patient
57 YR
- Death
- Death
Narrative
Description of Event or Problem
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.
Additional Manufacturer Narrative
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.