MAUDE Adverse Event Report: VAPOTHERM EXETER VAPOTHERM PRECISION FLOW UNITS

Model Number PRECISION FLOW

Device Problems Device Alarm System (1012); Battery failure (1055); Device Issue (2379)

Patient Problems Hypovolemic Shock (1917); Resuscitation (2400); Low Oxygen Saturation (2477)

Event Date 02/01/2014

Event Type  Injury  

Event Description

A vapotherm unit shut down while it was on a patient.The patient desaturated but the event was quickly responded to by the respiratory therapists and physician.There was not a therapist present when this unit shutdown.Our therapists said that upon arrival he found the unit shutdown but plugged into the wall.We pulled this unit and sent it in to the manufacturer for evaluation.They tested this unit and were unable to duplicate the failure but they did find that the batteries had not been changed and only lasted 1.5 to 2 minutes if the unit became unplugged for some reason.According to the manual, the internal battery should not require routine replacement and is not user accessible.After this event happened, we contacted the manufacturer and were told that the batteries should be changed every 2-3 years.However, unit was plugged into wall at time of incident so battery failure should not explain shutdown.Users of this device should have resources available to them that provide specific time lines when preventative maintenance is due.Since we feel the batteries may have played an important part in this event, battery replacement intervals should specifically be stated in the user manual.

• Brand Name: VAPOTHERM PRECISION FLOW UNITS
• Type of Device: VAPOTHERM
• Manufacturer (Section D): VAPOTHERM EXETER; NH
• MDR Report Key: 3846910
• MDR Text Key: 4409543
• Report Number: 3846910
• Device Sequence Number: 1
• Product Code: BTT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/17/2014,04/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PRECISION FLOW
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/01/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/14/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR
• Patient Weight: 75