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

Catalog Number MK06000

Device Problems Gas Output Problem (1266); Decrease in Pressure (1490); Intermittent Communication Failure (4038)

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

Event Date 01/26/2024

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 the unit stopped responding and the screen turned black.No injury reported.

Event Description

It was reported that the unit stopped responding and the screen turned black.No injury reported.

Manufacturer Narrative

A detailed log file analysis was performed by the manufacturer.On the reported date of event the described reboot could be confirmed- whereby the root cause could not be determined from the records.No further reboots were recorded, neither before nor after the date of event.The replaced pba therapy control unit m16.2 including the cf were assembled to a lab device and operated for 8 days while in total 1 reboot of less than 15 seconds was recorded.The related error codes filed in the log were similar to those from the submitted logfile.During a functional test of the m16.2 board no hardwar failure could be identified.Also the investigaton of the cf card did not reveal any functional limitation.Although no hardware failure was identified the therapy control unit m16.2 can be regarded as root cause of the reported symptom.In case of a reset of the processors of the therapy control unit m16 therapy is discontinued for a maximum of 15 seconds, before therapy will be resumed with the latest valid settings.For the current case the device returned to operation after 14 seconds.After replacement of the m16.2 board incl.Cf card, the device was tested and returned to use without further problems reported.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.The field failure rate is subject to permanent monitoring by the responsible product quality board and is rated as acceptable.

• 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: 18766100
• MDR Text Key: 336975758
• Report Number: 9611500-2024-00070
• 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
• Type of Report: Initial,Followup
• Report Date: 04/03/2024

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?: No
• Initial Date Manufacturer Received: 01/26/2024
• Initial Date FDA Received: 02/23/2024
• Supplement Dates Manufacturer Received: 03/28/2024
• Supplement Dates FDA Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2018
• 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