MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC INFINITY CENTRAL STATION; MONITOR, PHYSIOLOGICAL, PATIENT (WITH ARRHYTHMIA DETECTION OR ALARMS)

Device Problem Defective Alarm (1014)

Patient Problems Cardiac Arrest (1762); Death (1802)

Event Date 07/22/2017

Event Type  Death  

Manufacturer Narrative

The investigation has been started but not yet concluded.The results will be submitted in the follow up report.

Event Description

It was reported that a patient went into asystole and that there was no alarm generated at the central station.The patient had a signed do not resuscitate on file, therefore the doctor stopped resuscitation maneuvers.

Manufacturer Narrative

The strip report was evaluated and showed the asystole condition started at 08:02:35.At 08:02:51, the user was at the ics silencing an alarm for the cited bed (t528).This indicates that the user was responding to an alarm for the cited bed shortly after an asystole condition as seen on the strip report.Therefore an aysytole alarm was triggered.Based on this investigation, there were no malfunctions or errors identified with any of the involved draeger products.Additional information was received from the complainant confirming the patient death was not related to a draeger monitor or product.

Event Description

It was reported that a patient went into asystole and that there was no alarm generated at the central station.The patient had a signed do not resuscitate on file, therefore the doctor stopped resuscitation maneuvers.

• Brand Name: INFINITY CENTRAL STATION
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT (WITH ARRHYTHMIA DETECTION OR ALARMS)
• 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: 6753883
• MDR Text Key: 81396477
• Report Number: 1220063-2017-00046
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K061379
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/12/2017

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2017
• Initial Date FDA Received: 07/31/2017
• Supplement Dates Manufacturer Received: 07/25/2017
• Supplement Dates FDA Received: 10/12/2017
• Was Device Evaluated by Manufacturer?: No
• 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