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

Device Problem Insufficient Information (3190)

Patient Problem Skull Fracture (2077)

Event Date 10/23/2018

Event Type  Injury  

Manufacturer Narrative

Ge healthcare's investigation into the reported occurrence is still ongoing.A follow-up report will be issued when the investigation has been completed.Maude data base mdr report source # (b)(4).Device evaluation anticipated, but not yet begun.

Event Description

Anonymous report number #(b)(4) from maude database states, "rn responded to monitor alarming in pt room.Rn found patient lying on floor out of giraffe bed, crying, with bottom side rail down.Bed was found in the reverse trendelenburg position which is appropriate for pt.Rn hit emergency button and yelled for help.Second rn to bedside- picked pt up from first rn arms and placed pt back in bed.Pt was moving all four extremities appropriately and crying spontaneously.Picu team called apn and md to bedside to assess pt.Pt placed back on cardiac monitor and sipap machine after assessment.Neuro check done per md to assess pt status.Pt with appropriate neuro assessment.Q2 hour neuro checks ordered per picu team.Giraffe bed removed from room and new junior crib placed in room." additional information was received that the patient suffered a skull fracture from the fall.There was no reported additional medical intervention or extended hospital stay as a result of the fall.

Manufacturer Narrative

To address the reported event: 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 detect-ability of broken or cracked bedside panels.

Manufacturer Narrative

This supplemental mdr report is being submitted to link this mdr to recall (res# 82485; z-1846-2019 & z-1847-2019), as fda has classified this recall as class i.A.

• Brand Name: GIRAFFE WARMER
• Type of Device: WARMER, INFANT RADIANT
• Manufacturer (Section D): OHMEDA MEDICAL; 8880 gorman rd; laurel, MD 20723
• MDR Report Key: 8128410
• MDR Text Key: 129170727
• Report Number: 1121732-2018-00011
• Device Sequence Number: 1
• Product Code: FMT
• Combination Product (y/n): N
• PMA/PMN Number: K101788
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: FMI32067
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 35 DA
• Patient Weight: 4