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); Inaccurate Delivery (2339)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2021
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 there was a device failure during an ongoing niv ventilation of the patient.The device generated a "technical alarm" message, but ventilation of the patient was no longer possible.The affected device was immediately replaced by the staff on site.There was no patient injury.
Event or Problem Description
It was reported that there was a device failure during an ongoing niv ventilation of the patient.The device generated a "technical alarm" message, but ventilation of the patient was no longer possible.The affected device was immediately replaced by the staff on site.There was no patient injury.
Additional Manufacturer Narrative
The affected device was tested in the repair shop at the manufacturer¿s site and the log file was analyzed.The log file shows that the device detected a technical error on (b)(6) 2021 at 7.40 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 circuit board hpo.The device reacted 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.Based on the log file entries, it cannot be confirmed that ventilation was no longer possible as reported.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.Based on the final investigation result this case is no longer considered to be reportable according to the medical device regulation (mdr 2017/745).

• Brand Name: CARINA
• Common Device Name: VENTILATORS, OTHER
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 12703789
• Report Number: 9611500-2021-00439
• Device Sequence Number: 19743823
• Product Code: CBK
• UDI-Device Identifier: 04048675398516
• UDI-Public: (01)04048675398516(11)170810(17)171221(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: User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2021

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/12/2021
• Supplement Date Received by Manufacturer: 12/07/2021
• Initial Report FDA Received Date: 10/27/2021
• Supplement Report FDA Received Date: 12/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown