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

Model Number MK06000

Device Problems Decrease in Pressure (1490); Failure to Deliver (2338); Inaccurate Delivery (2339); Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/08/2020

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 tests passed and indicated fully operational and upon connection of the first patient on volume control the ventilator was not functioning ¿ nothing at all, flat line etco2, no chest rise, no air movement at all.¿ there was no injury reported.

Manufacturer Narrative

The electronic log file has been provided for evaluation.The log indicates that the system test was successfully completed in the morning of the date of event.Two procedures were performed on the respective day.The first one was suffering from the beginning from significant circuit leaks and the fresh gas deficit resulting therefrom.The device alarmed repeatedly for fresh gas low or leakage, apnea, minute volume low, inspiratory tidal volume high.The user switched multiple times forth and back between manual and automatic ventilation w/o any notable improvement of situation.The alarms persisted until the device was placed into standby after a total runtime of 1 hour and 9 minutes.Following the first procedure another system test was provided and passed.The second ventilation episode was started afterwards and was initially stable but then again intraoperative leaks were leading to a loss of pressure, volume and fresh gas.Several apnea and inspiratory tidal volume high alarms were given.The device was set to standby after half an hour.The investigation has not revealed any indication for the potential presence of a device malfunction.Dräger finally concludes that the device responded appropriately upon the disturbances of ventilation which were caused by leakages outside the device.

Event Description

It was reported, that ¿the tests passed and indicated fully operational and upon connection of the first patient on volume control the ventilator was not functioning ¿ nothing at all, flat line etco2, no chest rise, no air movement at all.¿ 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: 10372582
• MDR Text Key: 201876426
• Report Number: 9611500-2020-00277
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675253600
• UDI-Public: (01)04048675253600(11)180308(17)181025(93)MK06000-34
• 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: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MK06000
• Device Catalogue Number: MK06000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1