FDA Adverse Event
Other
Summary report: N
VAPOTHERM 2000I
MDR report key: 664280
·
Received January 11, 2006
Report
- Report Number
- 1125759-2005-00004
- Event Type
- Other
- Date Received
- January 11, 2006
- Date of Event
- December 16, 2005
- Report Date
- January 10, 2006
- Manufacturer
- VAPOTHERM, INC.
- Product Code
- BTT
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DR PRESENTED INFORMATION DURING A MEDICAL PRESENTATION SPECIFIC TO VAPOTHERM. HE PRESENTED A SLIDE WHICH READ: "VAPOTHERM ADVERSE EFFECTS: RUMORS AND FACTS." THESE INCLUDED: "WIDESPREAD INFECTION OUTBREAKS, WITHDRAWAL FROM THE ENTIRE USA MARKET, FACIAL AND CHEMICAL BURNS, RUPTURED EARDRUM. DR STATED THE INFECTION OUTBREAKS ARE BASED ON COLONIZATION REPORTS. AT THE TIME OF HIS PRESENTATION VAPOTHERM HAD NOT ISSUED A VOLUNTARY RECALL. THIS HAS OCCURRED; RECALL NOTIFICATION WAS MAILED DECEMBER 2005. HE STATED THE FACIAL BURNS WERE REPORTED IN A BULLETIN HE HAD SEEN. IN THIS CASE A NASAL CANNULA WAS CLEANED WITH AN UNDILUTED DISINFECTING CHEMICAL, NOT RINSED, AND PLACED ON A PATIENT. THE CHEMICAL CAUSED SKIN IRRITATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VAPOTHERM 2000I | HUMIDIFIER | BTT | VAPOTHERM, INC. | 2000I | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |