MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA PERSEUS A500; ANESTHESIA UNITS

Catalog Number MK06000

Device Problems Gas Output Problem (1266); Failure to Analyze Signal (1539); Failure to Deliver (2338); No Flow (2991)

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

Event Date 04/20/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.H3 other text : on-going.

Event Description

It was reported the unit went into boot cycle.No patient injury reported.

Manufacturer Narrative

The replaced parts were available for investigation.Non of the parts showed signs of burn or increased heat development.When tested in a lab device the pba blower a500 showed at least one faulty hall sensor.During a test run of the pba ther.Contr.Unit m16.2 in a lab device in total 5 reboots of less than 15 seconds were observed, but no cycling reboot.No hardware failures could be found.Although no specific hardware failure could be identified, the therapy control unit m16.2 can be regarded as cause for the (cycling) reboot.The subsequent blower failure was caused by a faulty hall sensor signal.The power supply (m7.3) was found to be fully functional.In case of a reset of the processors of the therapy control unit m16 therapy is discontinued for a maximum of 15 seconds, before therapy will be resumed with the latest valid settings.If for any reasons therapy was not restarted within 15 seconds an acoustical alarm will be given.Manual ventilation remains possible.

Event Description

It was reported the unit went into boot cycle.No patient injury reported.

• Brand Name: PERSEUS A500
• 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: 16972102
• MDR Text Key: 315865640
• Report Number: 9611500-2023-00187
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675253600
• UDI-Public: (01)04048675253600(11)211015(17)220222(93)MK06000-40
• Combination Product (y/n): N
• PMA/PMN Number: K133886
• 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: 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MK06000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/30/2021
• 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