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

Catalog Number 8416000

Device Problems Defective Alarm (1014); Inaccurate Flow Rate (1249)

Patient Problems Skin Discoloration (2074); Low Oxygen Saturation (2477)

Event Date 12/20/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that patient appeared to be gasping with every breath despite being on adequate ventilation.Co2 increased from 6 up to 10, saturations fell from 100 to 75 and the patient looked very pale and mottled.The patient was hand bagged which corrected saturations and co2.After reconnecting the patient, saturations fell and co2 increased again.The ventilator was not alarming anything but appeared not to be working properly.The graph on the ventilator did not seem to correlate with what it was delivering.Everything resolved once the patient was connected to a new ventilator.

Event Description

Please refer to the initial report.

Manufacturer Narrative

The device log file and the received information regarding the event provided basis for the investigation.No error entry indicating a device problem was stored.However several setting changes and ventilation related alarms (such as vt high, disconnection?) have been logged around the reported time of event (noon of (b)(6) 2018) indicating an insufficient ventilation set-up.The available data further indicates that a pressure controlled mode was used.In this mode the ventilation and applied volume is dependent on the present compliance and resistance conditions.Patient and breathing system can influence these characteristics.Further information regarding the set-up and settings were not available.Therefore no specific root cause can be identified and it cannot be derived why the change in ventilator reportedly corrected the issue.The results of the log analysis do not indicate a device malfunction.The customer report that the device did not alarm cannot be confirmed.The log entries show that several ventilation related alarms have been triggered as specified.

• 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: 8365773
• MDR Text Key: 136984890
• Report Number: 9611500-2019-00059
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 04048675042266
• UDI-Public: (01)04048675042266(11)160907(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: 04/17/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2000
• Device Catalogue Number: 8416000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/15/2019
• Initial Date FDA Received: 02/25/2019
• Supplement Dates Manufacturer Received: 03/04/2019
• Supplement Dates FDA Received: 04/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NA.; NA.
• Patient Outcome(s): Life Threatening