MAUDE Adverse Event Report: ACUTRONIC MEDICAL SYSTEMS AG MONSOON III; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number MONSOON III

Device Problem Computer Software Problem (1112)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/21/2021

Event Type  malfunction  

Manufacturer Narrative

Vyaire technical support received the log files sent by the customer.Log file analysis reveals "pip_to_high," a standard patient alarm in which set limit has been exceeded.However, this can be due to handling error as the pip (peak inspiratory pressure) channel has its own flow in order to avoid that a blockage of the channel goes unnoticed.Also, accidental changes are prevented by a double confirmation (operate touchscreen, then turn the rotary knob, confirm by pressing).The customer has been requested for more information (when it occurred, who discovered it, what application was used, how long is the operation time, what applicators were used) and photos of failure.The suspect device is in transit to manufacturer for evaluation.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

The customer reported that the settings changed by themselves, without touching the monsoon iii basic.It happened during patient ventilation.However, there is no information regarding outcome or intervention.

Manufacturer Narrative

Results of investigation: the suspect device was returned for investigation.Vyaire medical determined root cause as reproducible but not a failure but an operation of a command or a misinterpretation by the customer.

• Brand Name: MONSOON III
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): ACUTRONIC MEDICAL SYSTEMS AG; fabrik im schiffli; hirzel, 8816 ; SZ 8816
• MDR Report Key: 11399691
• MDR Text Key: 234281594
• Report Number: 3004553423-2021-00864
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K012691
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MONSOON III
• Device Catalogue Number: 212011
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/02/2021
• Initial Date FDA Received: 03/02/2021
• Supplement Dates Manufacturer Received: 04/06/2021
• Supplement Dates FDA Received: 05/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1