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

Catalog Number MK06000

Device Problems Complete Blockage (1094); Gas Output Problem (1266); Unexpected Therapeutic Results (1631); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 04/20/2021

Event Type  Injury  

Manufacturer Narrative

The investigation was started; results will be provided with a follow-up report.

Event Description

It was reported that a consistent peep was applied to the patient.It was further reported that extracorporeal cardiopulmonary support was necessary.

Event Description

It was reported that a consistent peep was applied to the patient.It was further reported that extracorporeal cardiopulmonary support was necessary.

Manufacturer Narrative

The electronic log file was available for investigation.The case in question could be reconstructed by means of the information stored therein and no indications for a device malfunction were found: the case in question was started in man/spont at 9:59am and continued in volume control.The last system test was successfully performed at 1:46am at the same day.The ventilation was subsequently inconspicuous and stable, the measured peep corresponded to the user setting, thus no peep/cpap high alarms were generated.It could be understood that there were repeated changes of therapy (between man/spont and volume control), most likely for therapeutic reasons.There were also repeated changes between low and high peep levels, probably for lung recruitment.Beginning at approximately 3:00pm, there were repeated significant increases in peak and plateau pressures (from approximately 20 to 40 hpa) while peep remained constant (set at 5 hpa at this time).The vte showed a reduction of about 50% during this phase.According to specification, the device repeatedly alarmed pressure high and volume not attained due to the set pressure limit.At 3:46pm, the user switched to standby.At this time, as further reported, the breathing system, tubing, and filter were changed while the patient was ventilated with an oxylog device.After successfully performing a system test, the therapy was continued from 4:16pm with the perseus and ventilation was subsequently stable and unremarkable again without further problems until the device was switched to standby at 5:21pm.Finally, the reported symptom could be partially reproduced based on the log analysis.Immediately prior to the change of the breathing system, there was an increase in peak and plateau pressures with peep according to the setting but reduced expiratory tidal volumes.This indicates a blocked filter or increased resistance in the expiratory path.There were no indications for a technical device malfunction found and the measured peep pressure corresponded to the set value at all times.Obviously, however, there was a significant delay in pressure relief on the patient side, resulting in an increase in pressure.The integrated pressure-, volume- and patient gas monitoring ensures that deviations from set or expected parameters are obvious and that alarms are given according to the alarm limits adjusted by the user.The device alarmed as specified.

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.

Event Description

It was reported that a consistent peep was applied to the patient.It was further reported that extracorporeal cardiopulmonary support was necessary.

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.

Event Description

It was reported that a consistent peep was applied to the patient.It was further reported that extracorporeal cardiopulmonary support was necessary.

• 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: 11744875
• MDR Text Key: 247938504
• Report Number: 9611500-2021-00189
• 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,Followup
• Report Date: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 04/22/2021
• Initial Date FDA Received: 04/29/2021
• Supplement Dates Manufacturer Received: 06/21/2021; 06/21/2021; 06/21/2021
• Supplement Dates FDA Received: 06/30/2021; 06/07/2022; 07/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2013
• 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
• Treatment: NA.; NA.; NA.; NA.
• Patient Outcome(s): Required Intervention