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

Device Problem Inappropriate or Unexpected Reset (2959)

Patient Problem Urinary Retention (2119)

Event Date 07/09/2019

Event Type  malfunction  

Manufacturer Narrative

The logbook of the affected device was available for the investigation.The log entries confirm that a warm start of the ventilation unit was carried out on (b)(6) 2019 at 11:52 pm.Ventilation was continued after the warm start.An unusually long duration of 9 months without switching off the device was identified as the cause of the warm start.The logbook entries show that the ventilator has been permanently switched on since (b)(6) 2018.Such a long time without switching off is highly unusual, as the device has to be switched off and the plug has to be pulled out according to the instructions for accessories assembly / disassembly and reprocessing.During a warm start of the ventilation unit, the emergency valve is opened against the environment to allow spontaneous breathing to the patient.After the successful warm start of the ventilation unit (duration approx.8 seconds), the alarm message "ventilation unit restarted" with accompanying acoustic alarm sequence is generated and ventilation is continued with the previously selected settings.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 the ventilator performed a restarted during ventilation.During this time, no ventilation was performed.No injury was 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
• Manufacturer Contact: sonja hillmer ; moislinger allee 53-55; lübeck 23542 ; GM 23542 ; 4518822868
• MDR Report Key: 8905293
• MDR Text Key: 186752364
• Report Number: 9611500-2019-00247
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 04048675042266
• UDI-Public: (01)04048675042266(11)170818(17)180616(93)8416400-18
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/31/2017
• 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