MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA PENDULA; MOUNTS, MONITOR

Catalog Number G16808

Device Problems Flaked (1246); Material Fragmentation (1261); Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/29/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation was started.A follow-up report will be sent as soon as the investigation is closed.

Event Description

A pendula device in operation room of the (b)(6) hospital has problems with paint letting loose.The pendula was in use during the event.No injury reported.

Manufacturer Narrative

The investigation was based on the affected pendula arms.The arms were replaced with new ones at the customer site and were sent to the manufacturer for analysis.It was found that due to a missing primer during the production process, the very smooth metal surface of the pendula was not properly prepared for the afterwards applied varnish.In the consequence it was possible that the applied varnish flakes from the flange.The failure in the production process have been corrected.According to the supplier, no further arms sold by dräger are affected by this failure.This is assessed to be a single occurrence.

Event Description

Please refer to the initial-report.

• Brand Name: PENDULA
• Type of Device: MOUNTS, MONITOR
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 7913887
• MDR Text Key: 122043004
• Report Number: 9611500-2018-00316
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• 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: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2000
• Device Catalogue Number: G16808
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1