MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA SAVINA; VENTILATORS, INTENSIVE CARE

Catalog Number 8414000

Device Problems Overheating of Device (1437); Aborted Charge (2288); No Apparent Adverse Event (3189)

Patient Problems Cyanosis (1798); Low Oxygen Saturation (2477)

Event Date 11/18/2023

Event Type  Injury  

Event Description

It was reported that the ventilator suddenly shut down during use.As per report, the patient showed clinical signs of desaturation.The users continued patient support with an ambu bag until a replacement device could be introduced.It was stated that the event did not lead to any further health consequences for the patient.

Manufacturer Narrative

The user facility did not involve the local dräger sales and service organization into examination of the device and did not provide a log file.It was reported that the device could be returned to use after the inlet filters have been cleaned as well as the interieur of the device has.Since no parts have been replaced, dräger concludes that the reported observation was not related to a device malfunction.The most likely explanation for the event is the following: the device has openings in the housing to take in ambient air for cooling the power supply and other internal subsystems.These openings are covered with filter mats to protect the inside from ingress of dust.The filter mats have to be checked on a regular base and replaced if necessary.If this is not done per manufacturer's recommendations, dust can increase the filter resistance and the air intake will be inhibited resulting in internal overtemperature.If the safety software of the device detects an overtemperature in the power supply, it will switch-off the power supply temporarily to allow the internal temperature to go back down.The device continues operation on battery and posts the alarm "internal battery does not charge" to indicate that the power-supply was switched-off for safety reasons.As soon as the temperature is back in normal range the power supply is automatically re-activated.The ifu clearly explains this type of alarm and the potential root causes.Based on the available information the device was apparently operated with an overaged or depleted battery which could not provide sufficient electric power after the power supply had switched off for safety reasons this explains the shut down.Dräger finally concludes that the reported event was related to other factors than technical issues the filter mats were not checked/replaced as required and the internal battery was not available as a back-up source of electrical energy.H3 other text : device not available for investigation, 3rd party service.

• Brand Name: SAVINA
• Type of Device: VENTILATORS, INTENSIVE CARE
• 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
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 18380042
• MDR Text Key: 331180013
• Report Number: 9611500-2023-00511
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K003068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8414000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: NA.
• Patient Outcome(s): Life Threatening