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

Catalog Number MK06000

Device Problems No Device Output (1435); Decrease in Pressure (1490); Inaccurate Delivery (2339); Gas/Air Leak (2946)

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

Event Date 05/06/2023

Event Type  malfunction  

Event Description

It was reported that the device failed during a case.No patient injury was reported.

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 that the device failed during a case.No patient injury was reported.

Manufacturer Narrative

For the investigation the logfile was analysed.Other than initially expected no indication for a malfunction of the device was found.It was possible to retrace the case in question and it was concluded that the descriped issue was most likely caused by a significant circuit leak leading to a loss of pressure, volume and fresh gas.The device issued several alarms (e.G.Fresh gas low or leakage, apnea, minute volume low) during the case as specified in order to call the attention of the user.According to the result of the investigation the case has been assessed to be not reportable in accordance to the meddev 2.12 document and mdr.

• 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: 16937508
• MDR Text Key: 315850836
• Report Number: 9611500-2023-00176
• Device Sequence Number: 1
• Product Code: BSZ
• 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: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2023
• 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: 06/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2016
• 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