MAUDE Adverse Event Report: VAPOTHERM PRECISION FLOW HIVNI; VAPOTHERM PRECISION FLOW

Model Number PRECISION FLOW HI-VNI

Device Problem No Apparent Adverse Event (3189)

Patient Problems Hypoxia (1918); Low Oxygen Saturation (2477)

Event Type  malfunction  

Manufacturer Narrative

Per the fda definition of a reportable event as defined in 21 cfr 803, vapotherm has determined that this complaint did not meet the definition of reportable, per the rationale provided below.However, out of an abundance of caution vapotherm is voluntarily reporting this event to the fda to respond to the customer's alleged product malfunction.The available information from the date that this decision tree was created, does not reasonably suggest that the precision flow device has malfunctioned.Per the details outlined by the customer, the vapotherm precision flow device alarmed for a "system fault error with the yellow triangle".The alarm then progressed to an error code 54.An error code 54 indicates that the air side mass flow sensor is out of range.This alarm code mitigates the risks associated with incorrect flow of medical gasses inside the pf-unit.When this alarm occurs, the user is instructed to disconnect the patient and shut off the unit.Per vapotherm's instructions of use the patient was disconnected and placed on alternate therapy.The device labeling also warns that this is not a life supporting device.The typical use environment will have alternate devices/therapies available such as other respiratory support devices, ventilators and manual breathing devices, if required.If a patient's condition deteriorates it would be standard of care to seek alternate therapy as indicated by the details of the complaint.Based on the initial details provided by the customer, no malfunction of the precision flow device occurred.The device performed as intended and alarmed as intended to indicate a disruption of therapy.See additional details in the evaluation summary of the investigated device in the attachment.The reported injury alleged within this event does not meet the definition of a serious injury because it was not life threatening and did not result in permanent damage to a body structure or body function.Use of an alternate therapy to provide respiratory support does not constitute medical intervention.Per device instruction for use, patients receiving supplemental oxygen are acute and appropriate clinical vigilance should be observed by the care team.Additional patient monitoring including pulse oximetry is necessary if the precision flow® hi-vni is used to give supplementary oxygen.If a patient's condition deteriorates it would be standard of care to seek alternate therapy as indicated by the details of the complaint.The delay in care that was outlined by the complainant is not related to the device as there was no malfunction of the device as outlined above.It is noted that the patient was on bilevel during the alleged delay in care, which indicates the patient was receiving alternate therapy and therefore there was no delay in care.

Event Description

The following complaint was received and logged by vapotherm on 21-nov-2022.(b)(6), customer reported that the device was running for twelve hours when a "system fault error" alarmed.The alarm then progressed to an error code ec 54.Customer reports that the patient then desaturated to 72% and was placed on a nonrebreather mask by icu staff as intermittent therapy prior to the arrival of the respiratory therapist (rt).Upon arrival of the rt, the patient was placed on bilevel to recover their oxygen saturation.The medical team was unable to reinitiate the precision flow.The rt states that there were no additional precision flowdevices available for usage.As an alternate therapy the rt placed the patient on a heated high flow nasal canula (hhfnc), however it is noted that the staff was delayed in locating a temperature cord, which is necessary for this alternate therapy.The delay in care to properly identify and initiate alternate therapy, is being considered a sentinel event by the icu team.

• Brand Name: PRECISION FLOW HIVNI
• Type of Device: VAPOTHERM PRECISION FLOW
• Manufacturer (Section D): VAPOTHERM; 100 domain drive; exeter NH 03833
• Manufacturer Contact: neeraj pardhy ; 100 domain drive; exeter, NH 03833 ; 6036580011
• MDR Report Key: 16024246
• MDR Text Key: 308376630
• Report Number: 3012971441-2022-00004
• Device Sequence Number: 1
• Product Code: QAV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: DEN170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PRECISION FLOW HI-VNI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2022
• Initial Date FDA Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other