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

Catalog Number	5704110
Medical Device Problem Codes	Failure to Deliver (2338); No Pressure (2994)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On site the logfile and the device were analyzed.It was found that the described shut down and restart in default ventilation was due to a faulty blower.If an unacceptable deviation between measured turbine rotation speed and the set value will be recognized during ventilation the technical alarm "blower defect" (00.A008) will be generated and the device will switch to patient safe mode.In this case the ventilation stops and the high priority alarm "device failure !!!" will be given.During this time an emergency breathing valve would open allowing spontaneous breathing of the patient.Ventilation of the patient with an independent ventilation device may be considered necessary.The device reacted as specified and gave the corresponding optical and acoustical alarms.The device has been repaired by exchanging the blower.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 unit shut down and then restarted during a case.There was no patient injury reported.

• Brand Name: CARINA
• Common Device Name: VENTILATORS, OTHER
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• MDR Report Key: 9283896
• Report Number: 9611500-2019-00369
• Device Sequence Number: 2352351
• Product Code: CBK
• UDI-Device Identifier: 04048675398516
• UDI-Public: (01)04048675398516(11)160817(93)5704110-11
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K072885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 10/08/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 5704110
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1