MAUDE Adverse Event Report: OHMEDA MEDICAL GIRAFFE OMNIBED CARESTATION; INCUBATOR, NEONATAL

Model Number 2082844-001-508846

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Burn, Thermal (2530)

Event Date 05/07/2018

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.Patient information could not be obtained due to country privacy laws.Unique device identifier: (b)(4).The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.Device evaluation anticipated, but not yet begun.

Event Description

The hospital alleged that the patient received overheating/burn while in the giraffee omnibed carestation.The system was being used in open warmer mode/baby mode.The hospital has been using baby mode only with probes placed into the patient diapers.Reportedly, the patient overheated and was cooled down, stabilized, and received higher fluids.It is suspected that the overheating occurred because of poor contact between the body and the probe which may cause an incorrect temperature reading and overshot of the power of infrared heater.The warmer was replaced.

Manufacturer Narrative

A gehc service representative performed a checkout of the unit in baby mode, as a radiant warmer, for 24 hours.The unit was found to function within manufacturer¿s specifications.As stated in the user manual, when using the radiant warmer in "baby mode¿, the system requires the baby¿s temperature to be measured on the skin of the infant using the temperature probe.This probe is to be properly attached on the abdomen area using a heat reflective patch and in the path of the radiant heat.In this instance, the hospital reportedly used the giraffe omnibed cs in baby mode with the probe placed in the infant¿s diapers.Probes, when placed inside the diapers, may not make proper contact with the baby¿s skin.An incorrectly applied skin probe with the probe not touching the infant skin can result in incorrect read-out (lower) of the baby temperature by the system.This improper placement may increase the radiant heater power output, resulting in the reported complaint.The cause of the reported complaint is user error.

• Brand Name: GIRAFFE OMNIBED CARESTATION
• Type of Device: INCUBATOR, NEONATAL
• Manufacturer (Section D): OHMEDA MEDICAL; 8880 gorman rd; laurel, MD
• Manufacturer Contact: john szalinski ; 3000 n grandview blvd.; waukesha, WI
• MDR Report Key: 7616584
• MDR Text Key: 111607482
• Report Number: 1121732-2018-00001
• Device Sequence Number: 1
• Product Code: FMZ
• Combination Product (y/n): N
• PMA/PMN Number: K152814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 07/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2082844-001-508846
• Other Device ID Number: SEE BLOCK H10
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/1970
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other