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

Catalog Number	5704110
Medical Device Problem Codes	Use of Device Problem (1670); Failure to Deliver (2338); Complete Loss of Power (4015); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a final-report.
Event or Problem Description
Patient was connected to the ventilator and niv used several hours.Unit was connected to mains all the time.Patient transport started and unit alarmed no external power connected, uses internal battery as normally.After apr.5 min of battery operation, the unit shut down without any warning or alarm.
Event or Problem Description
Patient was connected to the ventilator and niv used several hours.Unit was connected to mains all the time.Patient transport started and unit alarmed no external power connected, uses internal battery as normally.After apr.5 min of battery operation, the unit shut down without any warning or alarm.
Additional Manufacturer Narrative
The investigation was based on the reported event, logfile analysis and the information provided by the service technician onsite.The reported event, the shutdown could not be confirmed.The service technician checked the affected carina and found faulty dc power supply.Unit has been repaired and tested according to manufacturer specification.Battery itself was ok.According to the logbook the device did not show any "battery low" alarms and did not turn off due to an empty battery.If a device is disconnected from mains power, the device would give an alarm that the device has activated the internal battery and would switch to internal battery mode.The device operates until 22:18 pm when the device is switched off by the operator by pressing the power switch directly.The analysis of the logbook also shows that on the day of the reported event ((b)(6) 2021) the device was ventilating from 17:19 pm until 21:08 pm.At 21:08 pm the device was switched off by the operator.10 min later at 21:18 pm the device was switched on again and the device switched to internal battery mode at 21:47 pm.There are no logbook entry¿s between 21:48 pm and 22:18 pm.The logbook does not show any malfunctioning of the device.Since there are no logbook entries between 21:48 pm and 22:18 pm it is possible that the device switched to night mode.If the device is not actuated when night mode is set and no alarm is displayed, the screen switches off after 130 seconds.Earlier entries in the logbook also indicate that the device was often switched off directly at the main switch without activating the stand-by.

• Brand Name: CARINA
• Common Device Name: VENTILATORS, OTHER
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 11454801
• Report Number: 9611500-2021-00102
• Device Sequence Number: 4204413
• Product Code: CBK
• UDI-Device Identifier: 04048675398516
• UDI-Public: (01)04048675398516(11)181210(17)190330(93)5704110-12
• Combination Product (Y/N): N
• PMA/510(K) Number: K072885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2021

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
• Operator of Device: Health Professional
• Device Catalogue Number: 5704110
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/19/2021
• Supplement Date Received by Manufacturer: 03/15/2021
• Initial Report FDA Received Date: 03/10/2021
• Supplement Report FDA Received Date: 04/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1