MAUDE Adverse Event Report: DATEX-OHMEDA, INC. GIRAFFE OMNIBED CARESTATION; INCUBATOR, NEONATAL

Model Number 2082844-001

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Fall (1848)

Event Date 01/08/2020

Event Type  Injury  

Manufacturer Narrative

Incident description by customer: patient was discovered on the floor by the bedside nurse after hearing a soft thump.The patient was found lying prone (on stomach), naked, nasogastric feeding tube (ng tube), electrocardiogram (ecg) monitor leads, remained attached to the infant.The pulse oximeter sensor probe was attached to the patient, with the pulse oximeter sensor probe cable detached from the monitor.Patient had no visible bruising patient follow-up: a full body x-ray, cranial ultrasound, and cat scan (ct) results were negative for acute intercranial bleed, skull fractures, and any other injuries.To date, no additional interventions have been performed and patient has been stable.Ge healthcare's investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.Unique identifier: (b)(4).Report source other: medwatch mw5092271.Device evaluation anticipated, but not yet begun.

Event Description

On (b)(6) 2020, ge healthcare (gehc) was notified by (b)(6) medical center that at 7:05pm on (b)(6) 2020, a (b)(6) day old, (b)(6) week male patient was discovered on the floor by the bedside nurse.The patient had no visible bruising.Imaging tests were performed and results were negative.To date, no additional interventions have been performed and patient has been stable.

Manufacturer Narrative

The device in question was inspected twice by ge healthcare (gehc) and no defects were found on the portholes, porthole latches, or porthole springs.When the incident occurred, there were no witnesses and the responding nurse only saw that the porthole door was open.The customer was using a quilt as a cover for the giraffe omnibed carestation but, as of the gehc site visit, had stopped use of quilts as covers.The customer alleged that fmi posters were not received; however, two separate fmi 32070-2 kits (one delivered (b)(6) 2019 and the second delivered (b)(6) 2019) each of which included 3 posters per the kit bill of materials were shipped by gehc.The customer signed and returned fmi 32070 reply form 2 on (b)(6) 2020 which indicated that they received all components of kit, including the posters.With no equipment failures and no witnesses, we are unable to conclusively identify the root cause; however, based on this investigation three potential root causes are identified; potential root causes: 1.Incomplete fmi execution by the customer, 2.Incorrect use of quilt, 3.Operator did not close door properly.

• Brand Name: GIRAFFE OMNIBED CARESTATION
• Type of Device: INCUBATOR, NEONATAL
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• MDR Report Key: 9694710
• MDR Text Key: 186789711
• Report Number: 2112667-2020-00405
• Device Sequence Number: 1
• Product Code: FMT
• Combination Product (y/n): N
• PMA/PMN Number: K152814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2082844-001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/13/2020
• Initial Date FDA Received: 02/11/2020
• Supplement Dates Manufacturer Received: 02/27/2020
• Supplement Dates FDA Received: 03/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 29 DA
• Patient Weight: 2