MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA ATLAN A350; ANESTHESIA UNITS

Catalog Number 8621500

Device Problems Gas Output Problem (1266); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 10/31/2023

Event Type  malfunction  

Event Description

It was reported that the device stopped working after a power failure of the hospital.No injury was reported.

Manufacturer Narrative

The investigation was just started.The result will will be forwarded after the investigation was closed.H3 other text : on-going.

Manufacturer Narrative

For the investigation the logfile was analysed, however only limited information were available as part of the entries were already overwritten.Nevertheless, it was possible to retrace the described power supply failure of the hospital on the date of event.As specified the device switched to battery operation and continued ventilation until the mains voltage was available again.No stop of ventilation was found during logfile analysis.Further the logfile does not indicate any problem regarding the reliability of the back-up batteries.In case of a power supply failure, the device continues operation using the internal backup batteries without limitation of functionality while a power failure alarm is given.The remaining capacity of the batteries is indicated to the user and additional warnings are given when the residual battery charge is low respectively very low.Dräger finally concludes that the device behaved a s specified.

Event Description

It was reported that the device stopped working after a power failure of the hospital.No injury was reported.

• Brand Name: ATLAN A350
• Type of Device: ANESTHESIA UNITS
• 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: 18316375
• MDR Text Key: 330355858
• Report Number: 9611500-2023-00469
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K230931
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/02/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 8621500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2023
• Initial Date FDA Received: 12/13/2023
• Supplement Dates Manufacturer Received: 04/02/2024
• Supplement Dates FDA Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2021
• 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