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

Model Number MK06000

Device Problems Gas Output Problem (1266); Decrease in Pressure (1490); Failure to Deliver (2338); Intermittent Communication Failure (4038)

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

Event Date 02/24/2022

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 the screen went blank and the user lost their digital 02 flowmeter readings for about 10-15 seconds.The unit then came back up and the case was finished.There was no patient injury reported.

Event Description

It was reported the screen went blank and the user lost their digital 02 flowmeter readings for about 10-15 seconds.The unit then came back up and the case was finished.There was no patient injury reported.

Manufacturer Narrative

The logfile analysis carried out by the manufacturer revealed that a communication interrupt between the two processors onboard the therapy control unit have occurred during use.The device is designed to trigger a system reboot when such condition occurs.In case of such a reset, therapy will be interrupted for approximately 15 seconds.Afterwards, therapy will be continued with the last valid settings.Also in the particular case, the device behaved as specified after the reset and ventilation was continued without further problems until the case was completed by switching the device into standby mode.Although the source of the deviation can be attributed to the particular pcb, the exact nature of the issue cannot be determined due to its sporadic nature.The replaced pcb was assembled into a lab device and operated for 8 days without a reboot or other issues.The number of similar cases, related to the same phenomenon, is within the expected range of the respective risk assessment and thus accepted.The respective board has already been replaced as a precautionary measure; the workstation passed all consecutive tests and was returned to use without further problems 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: 13857597
• MDR Text Key: 297318447
• Report Number: 9611500-2022-00079
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675253600
• UDI-Public: (01)04048675253600(11)220120(17)220430(93)MK06000-40
• 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: 05/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• 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: MK06000
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2022
• 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.