MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA BABYLEO TN500; INCUBATOR, NEONATAL

Catalog Number 2M60000

Device Problems Poor Quality Image (1408); Improper Device Output (2953)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/07/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation was started but is not yet concluded.The result will be reported in a follow up-report.

Event Description

It was reported that a customer complains regarding an unclear x-ray image while using a tn500 during demonstration at a hospital.The x-ray image is not clear and allegedly shows cross stripe lines on the x-ray image due to the heated lines built in tn500 heated mattress when taking x-ray.Because of this phenomenon, doctor has a difficulty with the image interpretation.No patient consequences reported.

Manufacturer Narrative

The available information and the pictures sent provided basis for the investigation.Artefacts could be confirmed during analysis of the provided pictures.As no further information regarding the used x-ray technology and settings have been provided, it could not be assessed what had caused the artefacts in this specific case.It is not considered as a manufacturing quality issue.Normally the heated fine wires of the mattress do not impair image evaluation as the lines are negligible fine.However, system parts with higher density can superimpose to a visible pattern to x-ray image.The visibility also depends on chosen technology and settings and can make interpretation difficult if not set correctly.In case an unclear x-ray image cannot be interpreted, it might become necessary to repeat the procedure.The visibility of the heated wires can be minimized by optimal settings of the used x-ray technology or can be avoided by using a soft bed mattress.The number of similar cases is within the expected range of the respective risk assessment and thus accepted.

Event Description

Refer to the initial-report.

• Brand Name: BABYLEO TN500
• Type of Device: INCUBATOR, NEONATAL
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer Contact: sonja hillmer ; moislinger allee 53-55; lübeck 23542 ; GM 23542 ; 4518822868
• MDR Report Key: 6940065
• MDR Text Key: 90242157
• Report Number: 9611500-2017-00298
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K122821
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2000
• Device Catalogue Number: 2M60000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/11/2017
• Initial Date FDA Received: 10/11/2017
• Supplement Dates Manufacturer Received: 11/29/2017
• Supplement Dates FDA Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/31/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1