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

Catalog Number 5704110

Device Problems Fire (1245); Electrical Overstress (2924)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/27/2023

Event Type  malfunction  

Event Description

It was reported that a draeger device was connected to the electricity grid and it caught on fire after a power surge.Neither patient involvement nor user health consequences were reported.

Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.On-going.

Event Description

It was reported that a draeger device was connected to the electricity grid and it caught on fire after a power surge.Neither patient involvement nor user health consequences were reported.

Manufacturer Narrative

The affected device was made available for further investigation at the manufacturer¿s site.Based on the device inspection and the assessment of provided information the reported event could be verified.The inspection of the device shows that one of three capacitors was damaged and components in the vicinity of the damaged capacitor show traces of overheating and melting.The electrolyte capacitors are components of the electrical inlet circuit of the power supply.The observed damage is typical for an electrolyte capacitor, which was exposed to overvoltage.No further information was provided regarding the reported power surge on request, however, based on the investigation results it could be concluded that the mains voltage was beyond the tolerance limit of 264 v and caused the capacitor to fail.Overheating and melting of components was caused by the overheated and damaged capacitor but stopped autonomously.In the current event, neither patient involvement nor user health consequences were reported.The device was not in use during the event but was plugged in and charging.The manufacturer comes to the conclusion that the reported problem was caused by exposing the device to conditions outside of its technical specification of the device according to its instructions for use.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

• Brand Name: CARINA
• Type of Device: 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
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 16611678
• MDR Text Key: 311957560
• Report Number: 9611500-2023-00110
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K072885
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5704110
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2010
• 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.; NA.