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

Catalog Number MK06000

Device Problems Complete Blockage (1094); Gas Output Problem (1266); Increase in Pressure (1491); Obstruction of Flow (2423)

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

Event Date 02/16/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that a high pressure alarm raised and the volume target was not reached.Further, an obstruction was registered.In consequence the surgery was cancelled.No patient injury was reported.

Event Description

It was reported that a high pressure alarm raised and the volume target was not reached.Further, an obstruction was registered.In consequence the surgery was cancelled as no operational replacement device was available.No patient injury was reported.

Manufacturer Narrative

For investigation the log file was available.The reported event could be comprehended on basis of the log file.On the reported date of event prior the procedure the system test was cancelled after completion of the manual check list.During the case in question the device detected increasing airway pressures at constant tidal volumes.Subsequently the device alarmed with airway pressure high (paw >40 hpa) and tidal volume not achieved.The user switched back and forth between the modes without any improvement of situation.Several further airway pressure high and tidal volume not achieved alarms were given and the unit was placed in standby.Based on the information of the service technician and provided pictures a piece of plastic foil in the expiratory branch of the breathing system was found.The origin of this plastic foil and how it got in there is unknown.It can be concluded that this piece of plastic foil caused the obstruction leading to the increasing airway pressure.After removal of the plastic foil the device passed all tests.No indications for a technical malfunction of the device were found.An obstruction will be detected during sytsem test prior use.During use the integrated airway pressure monitoring allows a permanent control of pressure.In the case of high and/or continuous pressure situations appropriate alarms are given.If required, the pressure relief valve is opened in order to relieve pressure in the breathing system.

• 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: 16493819
• MDR Text Key: 310775987
• Report Number: 9611500-2023-00088
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675253600
• UDI-Public: (01)04048675253600(11)180601(17)190110(93)MK06000-35
• 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: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MK06000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 03/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2018
• 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
• Patient Outcome(s): Hospitalization