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

Device Problems Component Falling (1105); Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/20/2018

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be submitted upon completion of this investigation.

Event Description

The customer reported that the top of the infinity docking station (ids) came apart while in use and the delta monitor fell on a patient.No adverse patient impact was reported.

Manufacturer Narrative

The customer reported that an infinity docking station (ids) failed and the monitor fell off the docking station.No adverse patient impact was reported.The involved ids was evaluated by draeger.It was noted to be over 13 years old.Analysis showed the plastic housings which holds the pem nuts keeping the two halves of the ids together, were cracked and broken.This is consistent with internal stress pulling the pem nuts from the plastic housing and not a device malfunction.The stress damage can occur over time from attempting to remove the monitor while the locking mechanism is still engaged.The delta instructions for use states to move the lever to the left until it clicks.Use both hands to tilt the monitor forward and lift it off the ids or docking station.This information was provided to the complainant and the customer was provided a replacement ids for customer satisfaction.

Event Description

The customer reported that the top of the infinity docking station (ids) came apart while in use and the delta monitor fell on a patient.No adverse patient impact was reported.

• 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
• MDR Report Key: 7486517
• MDR Text Key: 107569521
• Report Number: 1220063-2018-00016
• Device Sequence Number: 1
• Product Code: DRQ
• Combination Product (y/n): N
• PMA/PMN Number: K050974
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 08/24/2018

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 Expiration Date: 01/01/2000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/23/2018
• Initial Date FDA Received: 05/04/2018
• Supplement Dates Manufacturer Received: 04/23/2018
• Supplement Dates FDA Received: 08/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1