InjuryJAX
HANS RUDOLPH
Received Mar 28, 1995 · Event occurred Jan 27, 1995
Report 39748-1995-00001 · MDR key 22091
Device
Generic name
Non Heated Pneumotach
Manufacturer
Hans Rudolph, Inc.Model number
8411ACatalog number
112830
Product problems
- Failure To Adhere Or Bond
- Labelling, Instructions for Use or Training Problem
- Inadequate Instructions for Healthcare Professional
Patient
*
- Respiratory Distress
Narrative
Description of Event or Problem
HOSPITAL STAFF SPECIFICALLY REQUESTED SUBJECT DEVICE TO BE DELIVERED TO THEM FOR USE ON THE ABOVE PT, OUR REP. COMPLIED.HOSPITAL REPORTS INCREASED RESISTANCE TO VENTILATION RELATED TO SUBJECT DEVICE.