MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC INFINITY DOCKING STATION IDS; PATIENT MONITOR DOCKING STATION

Catalog Number 7489375

Device Problem Component Falling (1105)

Patient Problem Bruise/Contusion (1754)

Event Date 12/20/2016

Event Type  malfunction  

Manufacturer Narrative

The investigation was started but has not yet been concluded.The investigation result will be reported in the follow up report.

Event Description

It was reported that a delta monitor fell on the patient.The ids¿ (infinity docking station) top half separated from the bottom portion, thus causing the delta monitor to fall.The patient was struck in the head and sustained a raised bruise to the forehead.The patient reportedly did not require any follow up intervention due to the bruise.

Manufacturer Narrative

The ids (infinity docking station) cited in this complaint was manufactured in april 2006.The complainant provided an update that the hospital technician glued the ids together.The ids was returned to dräger for analysis.The ids was disassembled and the plastic was found damaged where the six nuts in the ids top cover were glued.It could not be determined if this damage was incurred due to wear and tear over 10 years or fractured during disassembly due to the glue or a malfunction.It was confirmed that this ids was pull tested and passed on (b)(6) 2006.The ids is not under a regular service contract by dräger and there is no service history beyond the installation of the device on (b)(6) 2007.There are no other complaints that passed a pull test that have failed.As a warning from the ifu: if the device is mechanically damaged, or if it is not working properly, do not use it.Contact your hospital¿s technical personnel.Never perform monitor service or maintenance activities while actively monitoring a patient.In addition, as a caution from the ifu: this device must be inspected and serviced at regular intervals.A record must be kept on this preventive maintenance.We recommend obtaining a service contract with dräger service through your vendor.For repairs we recommend that your contact dräger service.When servicing devices from dräger, always use replacement parts that are qualified to dräger standards.Dräger does not warrant or ensure the safe performance of third-party replacement parts for use with the devices.

Event Description

See initial report.

Manufacturer Narrative

An error was made on the previous reports where the date received by manufacturer was omitted.The correct date is 12/30/2016 and has been added in this report.

Event Description

See initial report.

• Brand Name: INFINITY DOCKING STATION IDS
• Type of Device: PATIENT MONITOR DOCKING STATION
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC; 6 tech drive; andover MA 01810 2434
• Manufacturer Contact: dhaval trivedi ; 6 tech drive; andover, MA 01810-2434
• MDR Report Key: 6256120
• MDR Text Key: 65464161
• Report Number: 1220063-2017-00004
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050974
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 05/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2017
• 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: 7489375
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2006
• 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