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

Device Problems Device Handling Problem (3265); Excessive Heating (4030)

Patient Problem Burn(s) (1757)

Event Date 08/17/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that a new born required intesive care on top of dräger table, both heat radiator and mattress heating of the device babytherm 8010 was used.The nurse worked several hours with the patient by using the heated table, she had only short breaks.The nurse got burns to her right ear and burns were treated by ear doctor.No patient injury reported.

Manufacturer Narrative

The investigation was based on the description of event.Furthermore, the affected device was checked by hospital¿s biomed onsite and information regarding the technical status of the device was provided for manufacturer¿s assessment.Based on the investigation it was verified that parts of the human body as well as any other parts that are positioned within the infrared heater radiation beam will be heated up depending on their effective distance to the heat source and the time of exposure.In the current event it was reported that the nurse had worked several hours with the patient and had only short brakes.The device-specific instructions for use contain corresponding safety information which have the patient in focus, however, the risk management implies that the user understands the device functionality and can react to the situation accordingly.Warnings and cautions guide the user to closely monitor and control the applied temperature as well as highlight the fact that body parts positioned closer to the heat source will receive more radiation heat and can get hot.Reducing effective distance to the heat source and/or the time of exposure to the heat would have been an appropriate remedy in order to avoid an injury.According to the onsite device check there was no technical device failure found.Not following the instructions for use accordingly is therefore seen as root cause of the event.The babytherm 80xx device has been used around the world for more than 20 years without reporting an identical or similar case like this.Therefore, the current event was evaluated as single case.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

Event Description

It was reported that a new born required intensive care on top of dräger table, both heat radiator and mattress heating of the device babytherm 8010 was used.The nurse worked several hours with the patient by using the heated table, she had only short breaks.The nurse got burns to her right ear and burns were treated by ear doctor.No patient injury reported.

• 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: 10533630
• MDR Text Key: 206944284
• Report Number: 9611500-2020-00324
• 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: 12/18/2020

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/07/2020
• Initial Date FDA Received: 09/15/2020
• Supplement Dates Manufacturer Received: 12/08/2020
• Supplement Dates FDA Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NA.; NA.
• Patient Outcome(s): Required Intervention