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

Model Number PRECISION FLOW HIVNI

Device Problems Device Alarm System (1012); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Oxygen Saturation (2477); Respiratory Failure (2484)

Event Date 07/29/2023

Event Type  Death  

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 since this event involved patient death.The information gathered on this event thus far indicates that the unit was alarming for general faul alarm (gfa) with "- -" in o2 while the patient event occurred.Additionally, it was noted that the patient's condition was deteriorating before being placed on the precision flow device.On alarming the patient was placed on 100% o2 non-rebreather but continued to desat.The patient then was withdrawn from medical care and soon passed away.This alarm code indicates an incorrect mix of oxygen in the medical gasses supplied by the pf-unit.When this alarm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 information provided the device worked as intended and alarmed to indicate a disruption of therapy.The patient condition was deteriorating even prior to therapy being commenced on the vapotherm device.After the vapotherm therapy was discontinued and alternate therapy was chosen patient condition kept on deteriorating and patient was withdrawn from medical care followed by death of the patient.Per vapotherm's instruction for use, patients receiving supplemental oxygen are acute and appropriate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 is used to give supplementary oxygen.If a patient's condition deteriorates, and they spontaneously decompensate to where they are no longer spontaneously breathing, escalation of the therapy to more aggressive respiratory support (i.E.Intubation with mechanical ventilation), would be considered standard of care.Assisted breathing (i.E."being bagged") is usual and customary care for this patient population.This potential course of care is not unanticipated.Refer to manufacturer's evaluation summary attached for investigation details.Submission of this medical device report and the fda's release of that information is not an admission that product, user facility, distributor, manufacturer, or medical personnel caused or contributed to the event.

Event Description

The following complaint was received and logged by vapotherm on 04-august-2023 device serial number (b)(6) general fault alarm (gfa) with double dashes in fio2 (- - in o2).Vapotherm received the following information regarding this complaint: machine had been in use for approximately 3 hours at the time of the event.It was noted to be hooked up correctly.Unclear if the patient's pre existing declining condition or an alleged machine malfunction contributed to the patient decline in status.The unit gave a gfa (--) o2 alarm, at that time the patient was removed from the pf unit and placed on 100% o2 non-rebreather but continued to desat.The patient then was withdrawn from medical care and soon passed away.

• 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: 17653221
• MDR Text Key: 322317590
• Report Number: 3012971441-2023-00001
• Device Sequence Number: 1
• Product Code: QAV
• UDI-Device Identifier: 00841737101369
• UDI-Public: 00841737101369
• 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
• Type of Report: Initial
• Report Date: 08/31/2023

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 HIVNI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2023
• Initial Date Manufacturer Received: 08/04/2023
• Initial Date FDA Received: 08/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2022
• 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): Death