MAUDE Adverse Event Report: DATEX-OHMEDA INC. PANDA WARMER; WARMER, INFANT RADIANT

Device Problem Improper Flow or Infusion (2954)

Patient Problem Insufficient Information (4580)

Event Date 09/16/2021

Event Type  malfunction  

Event Description

1st event: infant delivered by c-section and required intubation and resuscitation.On attempt to transfer infant to nicu, air tank on transport warmer found to be empty.Infant had to be rapidly transferred to nicu on 100% o2.After speaking with nicu staff and resp therapists involved; the initial issue seemed to have stemmed from issues with the medical air tank at that time.The air and pressure gauges were working following the collaborative effort to trouble-shoot and correct what was believed to be an empty and/or bad tank at that time.The bed cleaned and placed back into use in the main c/s or (cesarean section operating room).2nd event: this is the second occasion that the same infant warmer failed.This time, the o2 from the oxygen tank would not work.In this case, the oxygen tank was not flowing through the warmer's built-in regulator, but the medical air side was flowing.Cpap pressure was maintained despite decreased/absent oxygen flow.After discussing the fact that this was the second issue with the tanks flowing improperly through the regulator; bed will remain out of service until manufacturer (ge) can inspect the bed.

• Brand Name: PANDA WARMER
• Type of Device: WARMER, INFANT RADIANT
• Manufacturer (Section D): DATEX-OHMEDA INC.; 3030 ohmeda drive; madison WI 53718
• MDR Report Key: 12518580
• MDR Text Key: 272954541
• Report Number: 12518580
• Device Sequence Number: 1
• Product Code: FMT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/17/2021

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/17/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/23/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1