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

Catalog Number 8603800

Device Problems Circuit Failure (1089); Failure to Deliver (2338); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.

Event Description

It was reported that the device had a ventilator failure.There was no patient injury reported.

Event Description

It was reported that the device had a ventilator failure.There was no patient injury reported.

Manufacturer Narrative

A dräger technician was dispatched to examine the device.It could be revealed by log file analysis that the ventilator failure did not occur during patient use - it was indeed already detected during self test.Unfortunately, the initial report was already filed before this information was made available and enabled the conclusion that the event is not reportable.The device is back in use after replacement of a pcb that caused the error in the self test.Dräger finally concludes that the self-test worked as intended; the device detected a restriction in functionality and brought it to the user's attention preventing from being used in this state.

• Brand Name: PRIMUS
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 11343832
• MDR Text Key: 250851378
• Report Number: 9611500-2021-00076
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675041436
• UDI-Public: (01)04048675041436(11)180411(17)180903(93)8603800-94
• Combination Product (y/n): N
• PMA/PMN Number: K042607
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• 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?: Yes
• Date Manufacturer Received: 03/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1