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

Catalog Number MK06000

Device Problems Device Alarm System (1012); Failure to Cycle (1142); Power Problem (3010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/02/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.

Event Description

It was reported that the device displayed a ventilator failure during the self test and that the error condition disappeared after power cycling of the device.The ventilation was however interrupted after approx.30 minutes of running surgical procedure.The users were reportedly bridging patient support in manual ventilation mode until a replacement device was available; no patient consequences have reportedly occurred.

Event Description

Please refer to initial mfr.Report #9611500-2019-00212.

Manufacturer Narrative

The log file evaluation revealed the following: after approximately 10 minutes into the procedure the supervisor function of the software detected failure of flow sensor calibration as well as a pressure sensor failure.The device shut down automatic ventilation to protect the patient from potentially harmful output.The corresponding alarms expiratory/inspiratory flow sensor not calibrated, pressure sensor failure and ventilator failure were posted.Patient support was continued in manual ventilation as reported.The recorded error codes indicate that the root cause for the deviation was an incorrect reference voltage for ad conversion on a certain pcb that processes the sensor signals.The particular pcb was replaced, the device was tested and is back in use.Dräger finally concludes that the device responded as designed to a deviation of that nature.When the flow and pressures sensor signals are rated as invalid during an ongoing ventilation episode this is a potential risk of generating harmful output.Thus, the safety concept defines a shut down of automatic ventilation in such a situation.As confirmed for the particular procedure, manual ventilation will further be possible.The overall ffr for the particular pcb is within the expected range of the respective risk assessment and thus accepted.

• 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: 8801676
• MDR Text Key: 151560533
• Report Number: 9611500-2019-00212
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675253600
• UDI-Public: (01)04048675253600(11)190405(17)191113(93)MK06000-36
• 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: 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2000
• Device Catalogue Number: MK06000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1