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

Catalog Number 8603800

Device Problems Use of Device Problem (1670); Human-Device Interface Problem (2949)

Patient Problem Insufficient Information (4580)

Event Date 08/30/2021

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 operator pressed a key during use but the device was irresponsive.The device was power-cycled but remained stuck in the boot sequence and could not be further used.There was no detail in the report which would reasonably suggest that patient consequences may have occurred.

Manufacturer Narrative

The dispatched fse has replaced the pcb which controls display and user interface.The device passed all consecutive tests and was returned to use without any further problems reported to date.The replaced pcb was returned to the manufacturer for evaluation.It was installed into the periphery of a lab device and subject to a long-term test run including several self-test procedures and ventilation episodes with different sets of ventilation parameter.This test run did not produce any findings, the lab device did not exhibit any deviations from specification.Since there was no other information like a log file available, the investigation remains inconclusive.

Event Description

It was reported that the operator pressed a key during use but the device was irresponsive.The device was power-cycled but remained stuck in the boot sequence and could not be further used.There was no detail in the report which would reasonably suggest that patient consequences may have occurred.

• 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
• MDR Report Key: 12531722
• MDR Text Key: 274232735
• Report Number: 9611500-2021-00405
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675041436
• UDI-Public: (01)04048675041436(11)180523(17)181017(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: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2018
• 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