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)

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

Event Date 07/04/2023

Event Type  malfunction  

Event Description

A ventilator failure has reportedly occurred during use of the device.It was explicitly mentioned that no health consequences for the patient were resulting from the event.

Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.H3 other text : on-going.

Event Description

A ventilator failure has reportedly occurred during use of the device.It was explicitly mentioned that no health consequences for the patient were resulting from the event.

Manufacturer Narrative

Other than initially reported, no ventilation failure occured during operation.The logfile analyses showed that during operation the ventilation was restricted due to intraoperative circuit leaks, leading to a loss of pressure, volume and fresh gas.The device issued several alarms (e.G.Fresh gas low or leakage, apnea, minute volume low) during the case to call the attention of the user.Further it was found that during standby a sporadic outage of the bag pressure sensor occured.Appropriate alarms were given to the user.During system test and leak test as well, internal and external leakages are detected and depending on size a conditional (yellow) or non-functional (red) state is the consequence.Based on leakage, fresh gas flow settings and set alarm limits during ventilation several audible and visible alarms would be issued (e.G.Apnea, minute volume low, volume/airway pressure not achieved).All alarms, possible causes and remedies are described in the instructions for use.Draeger finally concludes that the device detected and alarmed a deviation during operation.During standby, when no active ventilation takes place, a faulty bag pressure sensor was detected and alarmed according to specification.Regarding the faulty bag pressure sensor 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.H3 other text : on-going.

• 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: 17726890
• MDR Text Key: 323158019
• Report Number: 9611500-2023-00313
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675253600
• UDI-Public: (01)04048675253600(11)171123(17)180705(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: 11/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2023
• 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
• Date Manufacturer Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/30/2017
• 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