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

Catalog Number	5704110
Medical Device Problem Codes	Gas Output Problem (1266); Failure to Deliver (2338); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Event or Problem Description
It was reported that the carina displayed a technical alarm during use on a patient in combination with an optical and acoustical alarm.No patient injury reported.
Additional Manufacturer Narrative
The affected device was tested onsite by dräger service and the log file was secured for analysis.The log file shows that the device detected error a071 on (b)(6) 2021 at 3:11 p.M., which indicates a mechanical or electrical failure of the hpo (high pressure oxygen) unit.Based on this, the device was repaired by replacing the hpo valve.The device behaved as specified and alarmed the malfunction optically and acoustically.In response to the malfunction, the oxygen dosage is switched off and ventilation is continued using ambient air.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 or Problem Description
It was reported that the carina displayed a technical alarm during use on a patient in combination with an optical and acoustical alarm.No patient injury reported.

• 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: 11371416
• Report Number: 9611500-2021-00081
• Device Sequence Number: 3781352
• Product Code: CBK
• UDI-Device Identifier: 04048675041610
• UDI-Public: (01)04048675041610(11)160322(17)160614(93)8419350-28
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2021

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: 02/02/2021
• Supplement Date Received by Manufacturer: 03/15/2021
• Initial Report FDA Received Date: 02/24/2021
• Supplement Report FDA Received Date: 04/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1