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

Catalog Number 8603800

Device Problems Use of Device Problem (1670); Failure to Deliver (2338); No Apparent Adverse Event (3189)

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

Event Date 11/10/2022

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 shut down during use.There was no patient injury reported.

Manufacturer Narrative

Based on the logfile analysis, the case in question could be reconstructed but no indications for a device malfunction were found.The case in question was started at 10:40am using man/spont and continued in volume mode from 10:47am.29 seconds later, a regular (meaning that the power switch was pressed) power off was recorded.Thus, it can be concluded that the device was switched off by the user (un)consciously.The shutdown procedure contains a 10-seconds shutdown delay.The shutdown screen is displayed accompanied by an acoustic tone.During the shutdown delay, the device can be restarted immediately by pressing the main power switch again, as also described within the ifu.In this case, the ventilation will be continued with the last valid settings.Even if the device is powered off, manual ventilation as well as fresh gas dosage, using the o2 emergency delivery, including agent remains possible.Dräger finally concludes that the case is classified as non-serious incident and if investigation results were known before, the case would not have been rated reportable.

Event Description

It was reported that the device shut down during use.There was no patient injury reported.

• 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: 15975229
• MDR Text Key: 308078286
• Report Number: 9611500-2022-00341
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675041436
• UDI-Public: (01)04048675041436(11)150806(93)8603800-86
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/12/2023

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2022
• Initial Date FDA Received: 12/14/2022
• Supplement Dates Manufacturer Received: 12/20/2022
• Supplement Dates FDA Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2015
• 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