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); Reset Problem (3019)

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

Event Date 12/16/2021

Event Type  malfunction  

Event Description

During an emergency trauma or case in the middle of the night, the screen on the perseus froze and the anesthetist was unable to make any ventilator changes on the machine.No injury reported.

Manufacturer Narrative

The investigation was started, the result will be provided in a follow-up report.

Manufacturer Narrative

The provided information was analysed for the investigation.The description of the event and the fact, that the compact flash card was exchanged on side leads to the conclusion, that the reported symptom was most likely due to a faulty compact flash card causing a reboot of the device in question.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.During reboot the touchscreen is inoperable.The device was tested on site according to manufacturer's specification and returned into 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.

Event Description

During an emergency trauma or case in the middle of the night, the screen on the perseus froze and the anesthetist was unable to make any ventilator changes on the machine.No injury reported.

Manufacturer Narrative

Due to a technical issue with our internal emdr system we submitted for the form fda 3500a an incorrect value for the field h3.Not returned to manufacturer.

Event Description

During an emergency trauma or case in the middle of the night, the screen on the perseus froze and the anesthetist was unable to make any ventilator changes on the machine.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: 13059377
• MDR Text Key: 284683029
• Report Number: 9611500-2021-00530
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675253600
• UDI-Public: (01)04048675253600(11)180308(17)181025(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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/02/2022

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: MK06000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/17/2021
• Initial Date FDA Received: 12/22/2021
• Supplement Dates Manufacturer Received: 02/14/2022; 02/14/2022
• Supplement Dates FDA Received: 02/17/2022; 06/17/2022
• 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