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

Model Number MK06000

Device Problems Gas Output Problem (1266); Decrease in Pressure (1490); Failure to Deliver (2338); Reset Problem (3019)

Patient Problem Insufficient Information (4580)

Event Date 06/21/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is still on-going.The results will be provided with a follow-up report.

Event Description

It was reported that in the midst of a case the unit stopped working and stated cf card failure.There was no patient injury reported.

Event Description

It was reported that in the midst of a case the unit stopped working and stated cf card failure.There was no patient injury reported.

Manufacturer Narrative

The pba therapy control unit incl.Cf (compact flash) card was available for investigation.The components were tested in a lab device for three days without finding any deviations.Based on the log analysis the case in question was analyzed.It was found that due to a faulty cf card the device performed a reboot.The cf card failure was repaired by an automatic formatting triggered by the device.If the pba therapy control unit no longer can access the cf card the device performs a reboot.The therapy is discontinued for a maximum of 15 seconds, before therapy will be resumed with the last valid settings.If the reboot is not successful an acoustical alarm will be given and a "system failure" message is posted.Manual ventilation remains possible.Finally, the reported symptom is comprehensible and can be traced back to a faulty cf card.As due to the cf card failure relevant log entries were not recorded a detailed statement regarding given alarms is not possible.Reportedly, the device alarmed for a ¿cf card failure¿.Besides this, it can be assumed that also "loss of data", "therapy settings not applied" and "system failure" alarms were given.The pba therapy control unit inclusive cf were replaced and the device was returned to use.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

• Brand Name: PERSEUS
• 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: 14944640
• MDR Text Key: 297602665
• Report Number: 9611500-2022-00161
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675253600
• UDI-Public: (01)04048675253600(11)180129(17)180915(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: User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 08/24/2022

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 Model Number: MK06000
• Device Catalogue Number: MK6000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/23/2022
• Initial Date FDA Received: 07/07/2022
• Supplement Dates Manufacturer Received: 08/19/2022
• Supplement Dates FDA Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2018
• 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