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

Catalog Number 8603800

Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 12/27/2023

Event Type  malfunction  

Event Description

It was reported that during use on patient the anesthesia workstation failed to continue mechanical ventilation.Reportedly the affected device was immediately replaced by another device.No injury or serious impairment of patient´s state of health was reported.

Manufacturer Narrative

There was no involvement of manufacturers service representative after the reported event.It was reported by the user facility to the national authority only - including a prelimenary presumption of hospitals technician that the control module or air box failed.No further information could be obtained.The manufacturer concludes that due to the very limited information available no further investigation could be done and does not allow any conclusion about the root cause of the reported loss of mechanical ventilation.Finally it must be noted that the ventilation is monitored and displayed by the device, the loss of mechanical ventilation will be alarmed and the switch over to ventilate the connected patient manually should be possible - but this can not be verified for the reported case due to insufficient information.H3 other text : device not available for investigation.

• Brand Name: PRIMUS
• 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: 18690520
• MDR Text Key: 336426117
• Report Number: 9611500-2024-00052
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K042607
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/12/2024

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: 8603800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2024
• Initial Date FDA Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2013
• 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