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

Catalog Number FR00105

Device Problems Thermal Decomposition of Device (1071); Fire (1245); Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 08/30/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a serious incident caused skin burns to the baby and the nurse due to flames and hot particles came from the radiant warmer (heating compartment).The burns also caused damage to many parts of the device and the gel mattress.

Event Description

It was reported that a serious incident caused skin burns to the baby and the nurse due to flames and hot particles came from the radiant warmer (heating compartment).The burns also caused damage to many parts of the device and the gel mattress.

Manufacturer Narrative

The investigation of the reported event was based on the evaluation of the suspect material, photos, evaluation of the applicable user and maintenance instructions and additional information like email correspondences.Based on the results of the investigations, the incident could be confirmed.The root cause for the observed flames and hot particles remain unclear.The maintenance condition of the device was not up to date, as the heating elements were not replaced ontime and both reflectors were in poor condition and almost blind.The significant loss of reflection performance and the aging of heater resistance could cause a higher temperature load to the radiant heater housing while the radiation efficiency towards the patient decreases.Even if the ir heater element can create surface temperatures above 750°c there is no indication the parts provided for evaluation have actively burned by them self.The absence of clear igniting material and the given burn marks that indicating a rapid and larger fire pointing more to a ignition of combustible fluids or gases, however there is no information or evidence that potentially burnable or explosive fluids or gases been used for surface disinfection or treatment and has cause the fire.During onsite investigation cloth residues were found that most likely results cleaning procedures.The babytherm instructions for use (ifu) provides several warning and caution information regarding usage of flammable substances and damp cloths to avoid similar events.The heater elements are subject regular replacement interval or every 2years or 5000 h and must be replaced as couple.A field action has been performed in 2016 that points to the importance of heater element replacement each 2 years and included an ifu update.The device in question was part of the field action in 2016 and the proper information of the customer has been confirmed.After the incident, the device was repaired.The device is designed to meet the iec 60601-1 standard for basic safety and essential performance of medical electrical equipment and the risk of fire is minimized because the used materials are classified ul 94 v-0 or better.The event was a single occurrence.

• Brand Name: BABYTHERM 8010
• Type of Device: WARMERS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 10519978
• MDR Text Key: 206475819
• Report Number: 9611500-2020-00322
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/01/2022

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 Catalogue Number: FR00105
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/01/2020
• Initial Date FDA Received: 09/11/2020
• Supplement Dates Manufacturer Received: 06/27/2022
• Supplement Dates FDA Received: 07/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2013
• 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
• Patient Outcome(s): Required Intervention