MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA INFINITY ACS WORKSTATION CC; VENTILATORS, INTENSIVE CARE

Catalog Number 8416400

Device Problems Gas Output Problem (1266); Sensing Intermittently (1558); Tidal Volume Fluctuations (1634)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.

Event Description

It was reported that there was wired noise coming out of the flow sensor/expiratory valve area which is likely related to an disturbed ventilation.No patient consequences have been reported.

Manufacturer Narrative

The log file of the affected device and provided information built the basis for the investigation.The logged entries indicate a faulty cable harness flow sensor.The cable harness flow sensor is necessary to measure the expiratory flow, which is used for control and monitoring of the ventilation.In case the measurements are adulterated, influence on the ventilation is likely and an exceedance of set alarm limits triggers corresponding visual and audible alarms (e.G.Leakage alarms).In addition, a ¿chattering¿ noise may be observed close to the expiratory valve.However, ventilation does not completely stop.The ifu states as a warning: "if a fault is detected in the medical device, its life-support functions may no longer be assured.Ventilation of the patient using an independent ventilation device must be started without delay, if necessary with peep and/or an increased inspiratory o2 concentration (e.G.With a manual resuscitator)." there were no patient consequences reported.It can be concluded that the device alarmed as specified in order to alert the user to detected deviations.The suspected cable harness flow sensor has been already replaced on site.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

Event Description

It was reported that there was wired noise coming out of the flow sensor/expiratory valve area which is likely related to an disturbed ventilation.No patient consequences have been reported.

• Brand Name: INFINITY ACS WORKSTATION CC
• Type of Device: VENTILATORS, INTENSIVE CARE
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 11001685
• MDR Text Key: 221275563
• Report Number: 9611500-2020-00458
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 04048675042266
• UDI-Public: (01)04048675042266(11)160310(17)161124(93)8416400-16
• Combination Product (y/n): N
• PMA/PMN Number: K093633
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 01/20/2021

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 Catalogue Number: 8416400
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/24/2020
• Initial Date FDA Received: 12/14/2020
• Supplement Dates Manufacturer Received: 01/18/2021
• Supplement Dates FDA Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1