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

Catalog Number 8603800

Device Problems Gas Output Problem (1266); Failure to Analyze Signal (1539); Failure to Deliver (2338)

Patient Problem Low Oxygen Saturation (2477)

Event Date 02/04/2021

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 device posted a ventilator failure alarm at the beginning of the procedure.The patient was connected to another device; a temporary desaturation has reportedly occurred but this did not lead to any consequences.

Event Description

It was reported that the device posted a ventilator failure alarm at the beginning of the procedure.The patient was connected to another device; a temporary desaturation has reportedly occurred but this did not lead to any consequences.

Manufacturer Narrative

Evaluation and assessment were based on log file analysis.The given date of event was the (b)(6) 2021; for this date there was nothing relevant recorded.The log indicates that on (b)(6) 2021, the workstation could not complete the power-on self-test and came back with a ventilator failure due to a malfunction of the sensor that monitors the pressure inside the ventilator piston.This does not fit to the reported aspects of patient involvement and temporary desaturation; it was not possible to put the device into operation due to the failed self-test.The dispatched service engineer has replaced the pcb the failed pressure sensor is mounted to.The device passed all consecutive tests and could be returned to use.Dräger finally concludes that the self test worked as intended; the malfunction of the sensor was detected before a patient became involved.

• 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: 11586981
• MDR Text Key: 243915721
• Report Number: 9611500-2021-00133
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675041436
• UDI-Public: (01)04048675041436(11)170717(17)171211(93)8603800-93
• Combination Product (y/n): N
• PMA/PMN Number: K042276
• 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: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2021
• 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: 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1