MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA M26 MOUNTING SOLUTION; HINGED ARMS

Catalog Number G38714

Device Problems Detachment of Device or Device Component (2907); Device Fell (4014)

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

Event Date 11/30/2021

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 philips monitor, which was attached to the arm, fell down during use.Neither patient nor user health consequences were reported.

Manufacturer Narrative

The m26 arm provides an interface for the adaption of different monitors.This interface as part of the monitor head is realized via a slide plate and designed for a max.Load of 25 kg.Monitor-specific adapter plates can be attached via this slide plate in order to connect different types of monitors with the m26 arm.For philip monitors a specific adapter plate is available within the corresponding list of accessories.The affected m26 arm was made available for the investigation at the manufacturer¿s site.Based on the investigation it could be verified that the monitor head of the m26 had been modified: the m26 arm-specific slide plate of the monitor head had been removed and replaced by an adapter for the philips monitor.This unallowed modification included an enlargement of drill holes which are used to attach the slide plate.The examination the affected m26 arm also showed that a pin was missing which is essential to securely fix the connection between the monitor mount and the axis of the arm.It could not be excluded that excessive force during the enlargement of the drill hole had caused the loosening and detachment of the pin.The investigation therefore concluded that the detachment of the pin in the course of an unallowed product modification was most likely the root cause of the reported event.In the current event, there were no patient or user health consequences reported.However, detachment of a device from its mount and falling could result in an injury of the patient and/or personnel operating the device.According to the instructions for use of the m26 mounting solutions the system has to be checked regarding its operational readiness before each use including the fact that ¿all devices are firmly fastened to the mounting system¿.Furthermore, dräger recommends that the medical device is only used together with accessories listed in the current list of accessories.The ifu contains a warning that: ¿if other, incompatible accessories are used, there is a risk of patient injury due to medical device failure.¿ based on the investigation there was no design failure nor manufacturing failure found.The affected m26 arm has already been replaced.As no other complaints are known regarding this failure and root cause, the current event was evaluated as single event.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

Event Description

It was reported that the philips monitor, which was attached to the arm, fell down during use.Neither patient nor user health consequences were reported.

Manufacturer Narrative

Due to a technical issue with our internal emdr system we submitted for the form fda 3500a an incorrect value for the field h3.- not returned to manufacturer.

Event Description

It was reported that the philips monitor, which was attached to the arm, fell down during use.Neiher patient nor user health consequences were reported.

• Brand Name: M26 MOUNTING SOLUTION
• Type of Device: HINGED ARMS
• 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: 13008420
• MDR Text Key: 287113311
• Report Number: 9611500-2021-00502
• 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: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: G38714
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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