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

Catalog Number 8607500

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2019

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 a supporting arm which held a stand fell off the anesthesia machine.No patient injury reported.

Manufacturer Narrative

The investigation was based on the photos provided.These show that a wrong (too short) screws were used during installation.The assembly instructions are correct and describe the use of the correct screws.Due to the too short screws, the strength of the connection was reduced, which was the cause of the reported problem.This is an isolated case.

Event Description

Please refer to the initial-report.

• Brand Name: PRIMUS IE
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 9456946
• MDR Text Key: 179329148
• Report Number: 9611500-2019-00432
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675224747
• UDI-Public: (01)04048675224747(11)190919(17)240423(93)8607500-53
• Combination Product (y/n): N
• PMA/PMN Number: K042607
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8607500
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1