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

Catalog Number 8416000

Device Problem Loss of Power (1475)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/18/2019

Event Type  malfunction  

Manufacturer Narrative

The infinity acs workstation cc consists of two parts, the ventilation unit v500 and the cockpit unit c500.It was initially reported that only the cockpit c500 shut down during a case.In the course of manufacturer investigation the logfile was analyzed and it could be derived that the reported shut down was not limited to the cockpit c500.The ventilation unit performed a warmstart on the reported date of event as well.As a safety feature of the system, the safety software analyses and verifies proper function of the device.If the safety software detects an internal failure concerning the ventilator, a restart of the ventilation unit will be triggered with accompanying alarm.The restart sequence lasts for a maximum of 8 seconds.During that time the emergency-breathing valve remains open to ambient allowing for spontaneous breathing.No other entries have been logged which would indicate the reason of the logged warmstart of the ventilation unit.The exact root cause could not be identified based on the available information.

Event Description

It was reported the c500 shut down during a case.There was no patient injury.

• 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
• Manufacturer Contact: sonja hillmer ; moislinger allee 53-55; lübeck 23542 ; GM 23542 ; 4518822868
• MDR Report Key: 8502771
• MDR Text Key: 145122729
• Report Number: 9611500-2019-00119
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 04048675042266
• UDI-Public: (01)04048675042266(11)180601(17)181113(93)8416400-18
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093633
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2019
• Is this an Adverse Event Report?: No
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/31/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1