MAUDE Adverse Event Report: NATUS MEDICAL INC. OLYMPIC BILI-BASSINET

Model Number 58110

Device Problems Thermal Decomposition of Device (1071); Device Emits Odor (1425); Electrical Shorting (2926)

Patient Problems Jaundice (2187); No Consequences Or Impact To Patient (2199)

Event Date 03/09/2017

Event Type  malfunction  

Manufacturer Narrative

There are no prior complaints found in the natus complaint database.The event can be caused by shorting either in a faulty outlet or plug.It has not been determined if the device malfunctioned or if the incident was caused by a facility issue such as a malfunctioning wall outlet.The bili-band manual instructs the user to perform electrical safety testing according to the user facility's guidelines and after service.The manual also instructs users to perform annual inspections to assure patient and operator safety.Natus technical service has contacted the customer for information about the facility outlet safety check record and return of the power cord, but has yet to receive any response.

Event Description

The user facility submitted medwatch report (b)(4) on 3/21/2017.Natus subsequently received a copy of this report from the fda.This report described an adverse event involving a patient residing in the bili-bassinet, and the night shift rn walked into room and smelled something burning.She unplugged bili-bassinet from the wall plug and found a burn mark on the red electrical outlet and also on the bili-bassinet plug.The patient was immediately removed from the bili-bassinet and the bed was moved to hallway.The original intended procedure was treatment for high bilirubin levels.

Manufacturer Narrative

The complainant confirmed that a licensed electrician conducts annual testing of every outlet in the user facility.A photo of the power outlet involved in the event was provided.An engineer at natus evaluated the photo and determined that there were no signs of damage.The complainant was asked by natus technical service to examine the power outlet once more.The complainant examined the power outlet again and was unable to find any signs of damage.There had been some blackening of the power outlet, but it was easily wiped away.The blackening of the outlet was reportedly not due to electrical charring or melting of the plastic.Return of the bili-bassinet was requested by natus for evaluation, but the bili-bassinet was disposed of by the user facility.Because the bili-bassinet involved in the event could not be evaluated, the cause of the event could not be determined.

Event Description

The complainant confirmed that the patient was not harmed as a result of the event.There was no interruption in patient treatment and backup phototherapy equipment was available at the time of the event.

• Brand Name: OLYMPIC BILI-BASSINET
• Type of Device: BILI-BASSINET
• Manufacturer (Section D): NATUS MEDICAL INC.; 5900 first avenue south; seattle WA 98108
• MDR Report Key: 6562191
• MDR Text Key: 74999983
• Report Number: 3018859-2017-00297
• Device Sequence Number: 1
• Product Code: LBI
• Combination Product (y/n): N
• PMA/PMN Number: K971601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/21/2017,04/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 58110
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/21/2017
• Event Location: Hospital
• Date Manufacturer Received: 07/17/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 2 DA