MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC; WARMER, INFANT RADIANT

Model Number WBR 82-1

Device Problems Defective Component (2292); Failure to Deliver (2338)

Patient Problem Tachycardia (2095)

Event Date 05/15/2016

Event Type  malfunction  

Event Description

Turned o2 on to bag infant.O2 malfunction.No o2 coming through stabilett.Connections checked, visually intact.Infant hand carried to operating room #2 across the hall by backup nurse, primary nurse.Infant immediately placed on stabilett primary rn began bag/mask ventilation.O2 checked by 2 rn's (primary and orientee) prior to delivery- functioning.Infant hr rising per backup nurse.Anesthesiologist and nicu arrived in operating room and took over resuscitation.Infant began spontaneous movement.Apgars 1 and 8 at 1 and 5 minutes.Cord gas 7.20.Work order report: confirmed system failure.Worked with drager tech support to troubleshoot the issue.Replaced the power cord and the problem did not go away.Checked the ac filter and the breaker; traced the problem back to the power switch on the control panel.Replaced the power switch.Tech support said it is most likely a bad actuator inside the power switch.Tested all day for two days without failure.Performed operational inspection of the gases.Returned to service approximately 3 weeks after testing.

• Type of Device: WARMER, INFANT RADIANT
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC; 3135 quarry rd.; telford PA 18969
• MDR Report Key: 6089187
• MDR Text Key: 59479804
• Report Number: 6089187
• Device Sequence Number: 1
• Product Code: FMT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/30/2016

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: Nurse
• Device Model Number: WBR 82-1
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2016
• Event Location: Hospital
• Date Report to Manufacturer: 09/30/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1