MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA CARINA; VENTILATORS, OTHER

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Loss of Power (1475)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/28/2018

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 the unit was being used on a patient and the screen went blank and the unit powered off.They tried to power cycle the unit but it would not power on.They bagged the patient and swapped the unit out.No injury has been reported.

Event Description

Please refer to the initial report.

Manufacturer Narrative

The log file of the affected carina was analyzed.The log entries show that on (b)(4) 2018 at 3:46 pm the user tried to turn off the device directly from running mode by switching the power switch to off.The device has to be in standby mode to be shut down and cannot be switched off during an ongoing ventilation.The device displays the alarm message ¿set standby to shutoff¿ in this case.A few seconds later it was logged that the device alarmed ¿power supply fault¿ which indicates that the power cord was disconnected from the device and the power source changed to the internal battery.Afterwards the device continued the ventilation as set on battery power and was set to standby mode by the user at 4:01 pm.As the power switch was still in ¿off¿ position at that time, the device immediately shut down after being set to standby mode.There is no indication of a device malfunction from the log entries.The ventilation was performed as set until the device was set to standby mode by the user.

• Brand Name: CARINA
• Type of Device: VENTILATORS, OTHER
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 7561517
• MDR Text Key: 110039746
• Report Number: 9611500-2018-00160
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K072885
• 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: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• 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
• Date Manufacturer Received: 06/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1