MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC INFINITY DELTA / DELTA XL; PHYSIOLOGICAL MONITORING SYSTEMS

Device Problems Improper or Incorrect Procedure or Method (2017); Connection Problem (2900)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

Na.

Event Description

A complaint was received regarding an event that occurred about 1-1.5 months ago where the involved patient died while incorrectly connected to a delta monitor.Additional information was requested and the event description was clarified as when the nurse walked in the patient¿s room the delta monitor was in standby mode ¿ no one knew who put it into standby mode.It was noted that the staff often uses privacy mode and may have inadvertently selected standby mode.The device logs were not pulled at the time of the event, the device serial number was not documented and the device remains in use.There was no allegation of a draeger device malfunction or that the device played a factor in the patient outcome.The customer stated that no further information is available regarding the event.

• Brand Name: INFINITY DELTA / DELTA XL
• Type of Device: PHYSIOLOGICAL MONITORING SYSTEMS
• Manufacturer (Section G): DRAEGER MEDICAL SYSTEMS, INC; 6 tech drive; andover MA 01810 2434
• MDR Report Key: 10488140
• MDR Text Key: 205497697
• Report Number: 1220063-2020-00008
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• PMA/PMN Number: K152407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/13/2020
• Initial Date FDA Received: 09/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Death