MAUDE Adverse Event Report: OHMEDA MEDICAL GIRAFFE WARMER; WARMER, INFANT RADIANT

Model Number M1118179

Device Problem Protective Measures Problem (3015)

Patient Problem No Patient Involvement (2645)

Event Date 04/15/2019

Event Type  malfunction  

Manufacturer Narrative

No report of patient involvement.Ge healthcare (gehc) reported a field modification for this issue per 21 cfr 806 on 20 march 2019.The gehc internal field modification number is (b)(4).Customers were sent a letter explaining the issue and requesting the customer to inspect the warmer bedside panel latch areas.Replacement of broken bedside panels will be provided by gehc.A set of warning labels will be supplied for application to the bedside panels.These labels will warn the user to not use the bedside panels for maneuvering the warmer and indicate the correct method of maneuvering the warmer.An addendum to the operation and maintenance manual will also be provided emphasizing the need to check and ensure that the bedside panels and latches are not cracked, broken, or damaged before every patient use.The addendum will also contain instructions to increase detectability of broken or cracked bedside panels.

Event Description

The hospital reported that one of the rails is locked which could cause a patient fall.There was no report of patient involvement.

• Brand Name: GIRAFFE WARMER
• Type of Device: WARMER, INFANT RADIANT
• Manufacturer (Section D): OHMEDA MEDICAL; 8880 gorman rd; laurel, MD 20723
• Manufacturer Contact: john szalinski ; 3000 n grandview blvd.; waukesha, WI
• MDR Report Key: 8608607
• MDR Text Key: 146346403
• Report Number: 1121732-2019-00053
• Device Sequence Number: 1
• Product Code: FMT
• Combination Product (y/n): N
• PMA/PMN Number: K123309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 05/14/2019

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
• Device Model Number: M1118179
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/15/2019
• Initial Date FDA Received: 05/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: FMI32067
• Patient Sequence Number: 1