MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA CARINA; ANESTHESIA UNITS

Catalog Number 5704110

Device Problems Inaccurate Flow Rate (1249); Gas Output Problem (1266); Failure to Analyze Signal (1539); Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/23/2019

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 device failed during use.There was no injury reported.

Manufacturer Narrative

A representative of the local service organization has visited he user facility and checked the device.The log file was analyzed whereby it was determined that several instances of pressure sensor errors were recorded.The error condition was however not reproducible and thus, no parts were replaced.Further details were not made available to dräger.To protect the patient from potentially hazardous output the device is designed to switch to the so-called "rescue ventilation" mode when a monitoring of the airway pressure is at fault.In particular, the device continues operation in pressure-controlled ventilation but with trigger function is deactivated and volume guarantee option (vg) being no longer available.The airway monitoring functions are cut-off as well.The user is alerted to this condition by means of a corresponding alarm.A malfunction of the airway pressure monitoring function may be related to certain different root causes.Due to the fact that the error condition could not be duplicated in follow-up of the event, a further differentiation between the possible scenarios can't be made.Dräger finally concludes that the device responded as specified to a deviation of unknown origin.Since the device is intended to be used in sub-acute care, it can be considered that the rescue ventilation mode is suitable to bridge patient support until a replacement device is available.

Event Description

Please refer to initial mfr.Report #9611500-2019-00260.

• Brand Name: CARINA
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 8949240
• MDR Text Key: 156406631
• Report Number: 9611500-2019-00260
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K042607
• 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: 10/14/2019

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: 5704110
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/13/2019
• Initial Date FDA Received: 08/30/2019
• Supplement Dates Manufacturer Received: 09/27/2019
• Supplement Dates FDA Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1