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

Catalog Number	5704110
Medical Device Problem Codes	No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use, the device generated alarm and stopped ventilation - exchange to the standby equipment immediately.No injury or serious impairment of health of the patient reported.
Additional Manufacturer Narrative
The event was reported by the user facility to the national authority.Draeger was not involved in device check or analysis of the reported event.The device is not under maintenance contract with draeger und thus, no records about the actual service state are available.On request the hospital (icu manager) replied that a 3rd service provider performed the onsite check after the event and diagnosed the internal battery must be replaced.Reportedly the device is already back in use.No further information was available.Due to the very little information the manufacturer is not able to draw any conclusion about the root cause of the event or if appropriate measures and repairs by a 3rd party service provider has been performed after the event.Under consideration that the diagnosis is correct and comprehensive, it must be assumed that the device was not connected to mains supply at the time of event; otherwise either a defective battery would not have led to a complete shut down.It must be remarked, that the identical device was already subject to a reported event 3 weeks before the actual event, but the hospital refused an inspection or check of the affected device by draeger service organisation.

• 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: 15493291
• Report Number: 9611500-2022-00251
• Device Sequence Number: 1870426
• Product Code: CBK
• UDI-Device Identifier: 04048675398516
• UDI-Public: (01)04048675398516(11)160620(17)160929(93)5704110-11
• Combination Product (Y/N): N
• PMA/510(K) Number: K072885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/27/2022

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/08/2022
• Initial Report FDA Received Date: 09/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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