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

Catalog Number MK06000

Device Problems Failure to Deliver (2338); Device Sensing Problem (2917); Activation Failure (3270)

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

Event Date 03/12/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is still on-going.The results will be provided with a follow-up report.

Event Description

It was reported that the ventilator failed during use.No injury reported.

Event Description

It was reported that the ventilator failed during use.No injury reported.

Manufacturer Narrative

Investigation revealed that the description of event - "ventilator failure" - was misleading and led to reporting of an event which indeed can be considered non-reportable.The records in the log file indicate that the device was neither used on a patient on the reported date of event nor on the day before.In fact, the system test was repeatedly failed during these days due to an implausible signal from the sensor that monitors the pressure inside the manual breathing bag.Dräger finally concludes that the workstation responded as designed upon that deviation and brought the functional restriction to the user's attention before a patient became involved.

Event Description

It was reported that the ventilator failed during use.No injury reported.

Manufacturer Narrative

Due to a technical issue with our internal emdr system we submitted for the form fda 3500a an incorrect value for the field h3.- not returned to manufacturer.

• Brand Name: PERSEUS A500
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 11875749
• MDR Text Key: 255988619
• Report Number: 9611500-2021-00222
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/31/2022

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: MK06000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/27/2021
• Initial Date FDA Received: 05/25/2021
• Supplement Dates Manufacturer Received: 07/02/2021; 07/02/2021
• Supplement Dates FDA Received: 07/15/2021; 06/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2015
• 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