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

Catalog Number MK06000

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

Patient Problem No Information (3190)

Event Date 12/05/2020

Event Type  Injury  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.Initial log analysis revealed no hint for the potential presence of a device malfunction; a use error can however not be excluded to date.This report is filed in abundance of caution since patient outcome is not clear and, it cannot be excluded that medical intervention was performed.

Event Description

It was reported that impairments in ventilation occurred during a surgical procedure.The patient experienced a desaturation; further details are not known to date.

Event Description

It was reported that impairments in ventilation occurred during a surgical procedure.The patient experienced a desaturation; further details are not known to date.

Manufacturer Narrative

The investigation of the log file has revealed that the device passed the system test in the morning of the date of event w/o deviations.The concerned procedure was started in manual ventilation mode at 12:12.Already during this phase the device measured significant deviations between inspiratory and expiratory volumes which indicates a massive circuit leak outside the device.The device alarmed for apnea and fresh gas low or leakage to alert the user about the resulting fresh gas shortage.At this time, a fresh gas flow of 6.00 l/min (100vol% o2) was set and, the measured fio2 was in the upper nineties.Changeover to volume control mode was proceeded at 12.19 in combination with a reduction of fresh gas flow to 2.00 l/min and fio2 to 60vol%.The fresh gas deficit persisted, fio2 declined as expected.At 12:21 the user activated the emergency o2 delivery; fio2 jumped back to 98vol% but the minute volume delivered by the device was decreasing.A minute later the device recognized a sudden drop of fio2 to 21vol% and expsev to almost zero while the etco2 level remained nearly unchanged; values for airway pressure and flow were not measued anymore.Corresponding alarms were posted by the workstation.After approx.60 seconds the fio2 jumped back to 97%, expsev to ~3 vol% and volume and pressure values returned to the former levels.The situation however remained unstable; the patient was disconnected another five minutes later.All in all, no indication for the potential presence of a device malfunction could be found.The ventilation episode was disturbed already from the beginning by a massive leak in the pneumatic circuit.During the initial phase of manual ventilation the effects were measured and alarmed but the user may simply have adapted the way of squeezing the manual breathing bag and equalized the effects.But with switchover to automatic ventilation the leakage became more prominent and, the user-initiated reduction of fio2 and fresh gas flow has even worsened the situation.Between 12:22 and 12:23 the patient was obviously disconnected.Dräger finally concludes that there is no issue with the device which would require repair or correction.Appropriate alarms were posted; all alarms, potential root causes and dedicated remedies are listed in the ifu.

• 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: 11019273
• MDR Text Key: 221750300
• Report Number: 9611500-2020-00460
• 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: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• 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
• Date Manufacturer Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention