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

Model Number 100110

Device Problems Decrease in Pressure (1490); Infusion or Flow Problem (2964); No Pressure (2994); Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/30/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.Results will be provided in a follow up-report.

Event Description

It was reported that the device lost airway pressure and peep during a case.There was no injury reported.

Manufacturer Narrative

The device was inspected by a dräger service technician who replaced the blower unit and the peep valve drive and downloaded the electronic log file.Both was available for further investigation.The analysis of the returned parts has not revealed any failure.Within a two week endurance run the parts were operating properly.However, based on the information stored in the log the reported event could be reconstructed.During the case in question the device repeatedly detected significant deviations between the measured inspiratory and expiratory flow.Such deviation clearly indicates a huge leak within the patient system (connection of breathing hoses, tube, y-piece, etc.).The device generated corresponding alarms such as minute volume low, apnoe, fresh gas low or leak.The investigation has not revealed a device failure.The reported resetriction of ventiltion was caused by a relevant external leak.The device was tested and returned to use.

Event Description

It was reported that the device lost airway pressure and peep during a case.There was no injury reported.

• Brand Name: PERSEUS A500
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 10704176
• MDR Text Key: 212108926
• Report Number: 9611500-2020-00365
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100110
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1