FDA Adverse Event Malfunction Summary report: N

VAPOTHERM PRECISION FLOW(R) - HELIOX

MDR report key: 3539003 · Received December 24, 2013

Report

Report Number
3539003
Event Type
Malfunction
Date Received
December 24, 2013
Date of Event
November 8, 2013
Report Date
December 24, 2013
Manufacturer
VAPOTHERM INC
Product Code
BTT
Product Problem
Yes
Report Source
User Facility report
Reporter Location
IA, US

Narratives

Description of Event or Problem · 1

PATIENT WITH PAST MEDICAL HISTORY OF REACTIVE AIRWAY DISEASE, WHEEZING AND PNEUMONIA WAS ADMITTED WITH RESPIRATORY DISTRESS AND PNEUMONIA. PATIENT WAS RECEIVING VAPOTHERM RESPIRATORY SUPPORT OF 8 LPM AND 40% FIO2. TWO DAYS AFTER ADMISSION, DURING THE EVENING, RN REPORTED THAT VAPOTHERM SHUT ITSELF OFF. RN PROVIDED OTHER METHOD OF OXYGEN TO PATIENT, CALLED RESPIRATORY THERAPIST SAYING THE PATIENT'S VAPOTHERM HAD TURNED OFF BY ITSELF. RESPONDING RESPIRATORY THERAPIST NOTED THAT OXYGEN HOSE IN THE BACK OF THE VAPOTHERM MACHINE WAS VERY LOOSE AND LEAKING. RT FIXED THE HOSE PROBLEM AND VAPOTHERM THEN WORKED. LATER THAT NIGHT, THE VAPOTHERM SHUT ITSELF OFF AGAIN AND THE VAPOTHERM WAS REPLACED WITH A NEW MACHINE. DURING THESE 2 EPISODES, THE PATIENT RAPIDLY DESATURATED TO 89 BOTH TIMES. THE O2 SATS CORRECTED RAPIDLY ONCE THE PROBLEM WAS ADDRESSED. THE PATIENT CONTINUED ON VAPOTHERM TREATMENTS AND WAS DISCHARGED FOUR DAYS AFTER ADMISSION TO THE HOSPITAL, AFTER BEING SUCCESSFULLY WEANED OFF OF OXYGEN AND RESPIRATORY DISTRESS AND HYPOXIA WERE RESOLVED. THE PATIENT WAS ABLE TO REMAIN ON ROOM AIR FOR AN EXTENDED PERIOD OF TIME AND DURING SLEEP. VAPOTHERM UNIT WAS SEQUESTERED AT THE HOSPITAL FOR INVESTIGATION AND WILL BE RELEASED TO MANUFACTURER FOR NON-DESTRUCTIVE TESTING AFTER RECEIVING A SIGNED MEMO OF UNDERSTANDING (MOU). HOSPITAL RISK MANAGER WILL ISSUE AND OBTAIN A SIGNED MOU FROM VAPOTHERM INC.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
674405 VAPOTHERM PRECISION FLOW(R) - HELIOX HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) BTT VAPOTHERM INC * *

Patients

Seq Age Sex Outcome Treatment
1 3 YR