MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA BABYTHERM 8010; WARMERS

Catalog Number FR00105

Device Problems Loss of or Failure to Bond (1068); Detachment of Device or Device Component (2907); Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/14/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow up-report.

Event Description

It was reported that the open-unit heat lamp protective glass or filter glass of the phototherapy lamps were loose and fell onto the lying surface.The adhesive loosens and the glass falls out.There was no patient impairment reported.

Event Description

It was reported that the open-unit heat lamp protective glass or filter glass of the phototherapy lamps were loose and fell onto the lying surface.The adhesive loosens and the glass falls out.There was no patient impairment reported.

Manufacturer Narrative

The babytherm with the option phototherapy has two filter assemblies with 2x 3 filter glasses each.Each filter glass is glued with silicone adhesive on a carrier plate.For the investigation, the available information was evaluated and the suspected filter assemblies were assessed by the manufacturer (assembly 2m30302, "filter complete").The installation situation of the filter assemblies was analyzed.Based on the investigation it could be confirmed that all six filter glasses accessible from the outside were completely detached.Residues of the silicone adhesive were present in particular on the carrier plate, but also occasionally on the filter glasses; the silicone adhesive was still elastic, as with new parts, and returned slightly to its original shape after compression.The six filter glasses, which were not accessible from the outside in the original state of construction, were still firmly attached to the carrier frame and could be loaded with a weight of one kilogram without coming loose.No further damage was visible.It could not be conclusively clarified why the outer filter glasses had detached from the carrier plate.On the basis of the information provided on request, it is likely that the filter glasses were detached in the course of (repeated) surface cleaning or disinfection and the pressure applied in this process.This conclusion is supported by the fact that only the outer filter glasses - accessible for surface disinfection - are affected.In internal tests, the outer filter glasses only loosened at higher pressure and, moreover, initially only on one side and noticeably.Loose filter glasses of the phototherapy of the babytherm can lead to an injury or burn if they fall down.In the present case no patient injury was reported.Before putting the device into operation, the device must be checked for specified condition according to the instructions for use and repaired if the filter glasses are loose or missing.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

• Brand Name: BABYTHERM 8010
• Type of Device: WARMERS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 9479578
• MDR Text Key: 183758898
• Report Number: 9611500-2019-00446
• Device Sequence Number: 1
• Product Code: FMT
• Combination Product (y/n): N
• PMA/PMN Number: K971198
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FR00105
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1