MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA INFINITY ACS WORKSTATION NC; VENTILATORS, INTENSIVE CARE, NEONATAL /PEDIATRIC

Catalog Number 8417400

Device Problem Loss of Power (1475)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/02/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that the vn500 shut down while in use.There was no injury reported.The patient was switched to another ventilator.

Manufacturer Narrative

The infinity acs workstation nc consists of two main parts which operate mostly independent of each other.The ventilation unit vn500 performs the ventilation and the cockpit c500 is the main display and allows for user input.The affected device was checked by dräger service and the log files were provided to the manufacturer for further analysis.During testing of the device initially the m16 board (part of the cockpit) and later the complete cockpit were replaced.A full functional test according to manufacturer specification passed without deviation after the repair.An evaluation of log entries on the reported date of event (april 2nd) was not possible as there were no entries between april 1st and april 4th.This lack of log data corresponds with the finding of a faulty cockpit during the device test.It could be concluded that a persistent error of the cockpit was the root cause for the issue.Due to the missing log data it is not possible to determine if the ventilation was stopped in this case.The device permanently analyzes and verifies its proper function.In case of a temporary deviation of the c500 a restart gets initiated in an attempt to solve the issue and reset the micro processing system to a specified state.The vn500 is generally not affected by a c500 restart and continues ventilation with the current settings.Safety relevant parameters such as fio2, minute volume, or airway pressure are displayed in the supplemental oled-display on the vn500 wherein the user can observe the on-going ventilation.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

Please refer to the initial-report.

• Brand Name: INFINITY ACS WORKSTATION NC
• Type of Device: VENTILATORS, INTENSIVE CARE, NEONATAL /PEDIATRIC
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 8564060
• MDR Text Key: 143598202
• Report Number: 9611500-2019-00136
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 04048675250418
• UDI-Public: (01)04048675250418(11)171205(17)180519(93)8417400-16
• Combination Product (y/n): N
• PMA/PMN Number: K093632
• 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: 07/01/2019

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 Expiration Date: 01/01/2000
• Device Catalogue Number: 8417400
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/16/2019
• Initial Date FDA Received: 04/30/2019
• Supplement Dates Manufacturer Received: 06/18/2019
• Supplement Dates FDA Received: 07/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1