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

Device Problems Kinked (1339); Use of Device Problem (1670); Insufficient Flow or Under Infusion (2182); Application Program Problem: Medication Error (3198)

Patient Problems Hematoma (1884); Low Blood Pressure/ Hypotension (1914)

Event Date 05/16/2016

Event Type  Injury  

Manufacturer Narrative

The patient information is unavailable because the initial reporter identity is unknown and can't be contacted.Ge healthcare contacted fda for initial reporter information from the user report but the agency will not provide it.The date of manufacture is unknown because system serial number information was not included in the user report.Ge healthcare¿s investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.

Event Description

A ge healthcare review of the fda maude database found report number (b)(4) where a user facility reported that a two week old infant born at (b)(6) gestation was being treated with dopamine for hypotension when the tubing for the dopamine became kinked in an incubator door so that there was very little dopamine flowing and the blood pressure drifted downward.The clinical team kept increasing the dose of dopamine with no effect until the kinked tubing was found.After opening that tubing, the blood pressure went up to 60 rapidly.Everything was turned off, and over the course of an hour the mean pressure came down to 40.This resulted in a parafalcine subdural hematoma.

Manufacturer Narrative

This reported event was discovered by ge healthcare during a routine fda maude database search.No serial number or customer contact information was provided in the maude report, and only limited event details were available.No formal mdr has been received by ge healthcare related to this event to date.A search of the complaint database was performed from january 2011 to december 2016, and no similar reports were noted.The fda was contacted to obtain customer details for further contact but this information would not be disclosed.The giraffe omnibed operator's & maintenance manual, revision zab, states on page 3-5 (operating the omnibed section): ¿*warning: when opening or closing the doors or portholes, make sure the infant, any clothing, monitoring leads, tubing, etc., are completely within the confines of the bed.Inspect all patient connected tubes or leads before and after sliding out, rotating, tilting, raising or lowering the bed.¿ the giraffe omnibed has 17 built in tubing access covers or grommets that the clinician can use to thread wires, iv tubing, tube feeders, temperature probes, ventilator tubing, etc.From the limited information provided in the maude report, it appears the iv tubing was not properly fed through the designed appropriate tubing access cover and was pinched in an incubator door.Not knowing the extent or degree of blood accumulation in the parafalcine subdural hematoma of this patient, it is not known the degree of injury received.Based on the ge healthcare investigation of this event, no further actions are warranted at this time.

• Brand Name: GIRAFFE OMNIBED
• Type of Device: NEONATAL INCUBATOR
• Manufacturer (Section D): OHMEDA MEDICAL; 8880 gorman rd.; laurel MD
• Manufacturer Contact: joseph seliga ; 3000 n grandview blvd.; waukesha, WI
• MDR Report Key: 6178079
• MDR Text Key: 62477579
• Report Number: 1121732-2016-00003
• Device Sequence Number: 1
• Product Code: FMZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101788
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/17/2016
• 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