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

Catalog Number MK06000

Device Problems Failure to Deliver (2338); Device Sensing Problem (2917); Activation Failure (3270)

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

Event Date 08/30/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation has been started; results will be provided within the follow-up report.

Event Description

It was reported that there was a vent failure message.Patient involvement could not be excluded.There was no injury reported.

Manufacturer Narrative

Based on the device log analysis it was found that on the reported date of event a faulty bag pressure sensor was detected during the system test.The offset voltage of the bag pressure sensor was found to be out of specification.The bag pressure sensor monitors the filling volume of the breathing bag connected to the breathing system and provides information concerning the available volume for inspiration.Therefore, automatic ventilation cannot be started if a faulty pressure sensor is detected during the system test.As initially reported a ventilator failure occurred during use.This could not be confirmed by means of the log records.Even if the bag pressure sensor did fail during use, a ventilator failure would not be the consequence; a sensor drift might lead to incorrect alarm priorities (fresh gas deficit alarms of cascaded priority are triggered by this pressure sensor) as well as a faulty econometer level.However, fresh gas dosage is not affected and independent from the pressure signal, additional pressure- and flow-related alarms are given in case of an actual fresh gas deficit.The filling level of the breathing bag is further visible to the user.Finally, it can be concluded that the device reacted as specified by detecting the faulty pressure sensor during the system test.In this state automatic ventilation cannot be activated.The pressure sensor was replaced and the unit can be put back into operation.It can be concluded that based on the investigation results the case is assessed as non-reportable and should not have been reported initially.

Event Description

It was reported that there was a vent failure message.Patient involvement could not be excluded.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 ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 15469260
• MDR Text Key: 303747216
• Report Number: 9611500-2022-00243
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675253600
• UDI-Public: (01)04048675253600(11)170316(17)180203(93)MK06000-33
• 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: 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 09/07/2022
• Initial Date FDA Received: 09/22/2022
• Supplement Dates Manufacturer Received: 09/07/2022
• Supplement Dates FDA Received: 11/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2017
• 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