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

Device Problem Defective Alarm (1014)

Patient Problems Bradycardia (1751); Respiratory Distress (2045); Pallor (2468)

Event Date 02/12/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that when entering a patient's room, their face color was not okay, they were bradycardic and gasping.The monitor did not show a red alarm, only an information alarm.Resuscitation was performed and the patient was stabilized.

Event Description

It was reported that when entering a patients room, their face color was not okay, they were bradycardic and gasping.The monitor did not show a red alarm, only an information alarm.Resuscitation was performed and the patient was stabilized.

Manufacturer Narrative

It was reported that intervention was required on a patient connected to a gamma xl monitor because they received an information alarm, not a red alarm, for bradycardia.Draeger confirmed from the provided images that the gamma xl was alarming for spo2, heart rate and respiration rate at the date and time of the reported event.The images also confirmed the device being used to monitor the adult patient was in adult mode.Draeger states in the gamma xl monitor's ifu that in adult mode, the gamma xl monitor triggers life-threatening (red) alarms for asystole, ventricular fibrillation and ventricular tachycardia.It does not trigger life-threatening (red) alarms for bradycardia in adult mode.Since the gamma xl was being used on an adult in adult mode, the user would not receive a red alarm for bradycardia, as explained in the gamma ifu.There was no malfunction of the device.Our device was working as designed and can be excluded from the patient event.

• Brand Name: INFINITY GAMMA XL
• Type of Device: PHYSIOLOGICAL MONITORING SYSTEMS
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC; 6 tech drive; andover MA 01810 2434
• MDR Report Key: 8350507
• MDR Text Key: 136502946
• Report Number: 1220063-2019-00007
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• PMA/PMN Number: K053484
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/15/2019

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
• Initial Date Manufacturer Received: 02/13/2019
• Initial Date FDA Received: 02/19/2019
• Supplement Dates Manufacturer Received: 02/13/2019
• Supplement Dates FDA Received: 03/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1