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

Catalog Number 5704110

Device Problems Failure to Run on Battery (1466); Failure to Deliver (2338); Insufficient Information (3190); Complete Loss of Power (4015)

Patient Problem No Information (3190)

Event Date 01/22/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported during use that the unit had shut down while inserting and a-line.Cpr was performed and the patient was then bagged and no injury was reported.A dräger technician evaluated the unit and the device logs.The logs indicated that the unit had went on battery and then the battery had depleted with in 4 minutes.The unit is currently out of use pending service.

Manufacturer Narrative

The investigation was based on the reported event and logfile analysis.Onsite a dräger service technician examined the affected device.It could be confirmed via the logbook entries that the device had a shut down due to a depleted battery.According to the log file the device switched to battery mode at 03:53 pm on the date of event.At 04:42 pm and at 05:01 pm the device alarmed for ¿battery low¿ in increasing priority.At 05:06 pm the device alarmed ¿battery empty¿ and at 05:12 pm the device shut down.11 minutes later the device was switched on again.At 5:25 pm the devices switched to battery mode and alarmed for an empty battery at 5:26 pm and 5:29 pm before shutting off in the same minute.Based on the log entries the device operated and alarmed the remaining battery capacity as specified.In addition, the internal battery was not sufficiently charged after it was emptied at 5:12 pm.If a device is disconnected from mains power, the device gives an alarm that the it has activated the internal battery and would switch to internal battery mode.No device malfunction could be detected during the on-site investigation either.

Event Description

It was reported during use that the unit had shut down while inserting and a-line.Cpr was performed and the patient was then bagged and no injury was reported.A dräger technician evaluated the unit and the device logs.The logs indicated that the unit had went on battery and then the battery had depleted with in 4 minutes.The unit is currently out of use pending service.

• Brand Name: CARINA
• Type of Device: VENTILATORS, OTHER
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 11383890
• MDR Text Key: 233734288
• Report Number: 9611500-2021-00091
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072885
• 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,Followup
• Report Date: 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 5704110
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2015
• 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
• Patient Outcome(s): Required Intervention