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

Model Number M1118179

Device Problems Break (1069); Crack (1135)

Patient Problem Injury (2348)

Event Date 05/23/2019

Event Type  malfunction  

Event Description

Upon doing safety check assessment of side rails, the side rail clip malfunctioned.It was found to be broken/cracked similar to another bed that resulted in a serious injury to the infant.

• Brand Name: GIRAFFE
• Type of Device: WARMER, INFANT RADIANT
• Manufacturer (Section D): DATEX-OHMEDA, INC; 3030 ohmeda drive; madison WI 53718
• MDR Report Key: 8764108
• MDR Text Key: 150139006
• Report Number: 8764108
• 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: 05/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: M1118179
• 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: 05/30/2019
• Event Location: Hospital
• Date Report to Manufacturer: 07/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1