MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA BABYTHERM 8004; WARMERS

Catalog Number 2M30404

Device Problem Break (1069)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 01/14/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that a photo therapy (halogen) light shattered.As a result of the shattered lamp the baby received burns from the shards of glass - 12-14 blister burns.It was confirmed the infant is recovering from the incident.

Manufacturer Narrative

A dräger service technician was onsite and carried out the repair.Photos of the affected device onsite and the damaged halogen bulb were provided for the investigation at the manufacturer.The returned philips halogen lamp characteristics correspond with the specified requirements in the accompanying device information.The time counter of the photo therapy shows 946 hours which is shortly below the specified replacement interval of the bulbs (1.000 hours).During an optical evaluation it could be confirmed that the cover glass and the glow wire were broken and that there were cracks in the reflector housing.The pins and isolation ceramics show no signs of damage or increased heat.Based on the available information it was concluded that a malfunction of the halogen bulb was the root cause for the issue.The photo therapy option for the baby therm 8004 includes six halogen lamps.In case of a malfunction of one lamp, four lamps would still be operational (two are connected in series).The manufacturer of the halogen bulb stated that the typical malfunction is a burned wire still enclosed by the burner or at least the reflector compartment.In extremely seldom cases a bulb malfunction results in a damage of both compartments.Furthermore, two filter glasses are located in front of the bulb in the baby therm in order to prevent glass pieces from directly falling down.However, due to cooling reasons this is not completely sealed and it is possible that some parts fall though the sideward positioned ventilation slots.Eye protection is mandatory for the patient when the photo therapy is in use.The patient in this case suffered minor non-permanent burn injuries.Two similar cases were reported to dräger since 2001.However, in one case the user taped off the cooling vents which led to overheating of the halogen bulb and in the other case the halogen bulb was around 3.000 hours in use.Therefore, 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

Please refer to the initial-report.

• Brand Name: BABYTHERM 8004
• Type of Device: WARMERS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 8292235
• MDR Text Key: 134572898
• Report Number: 9611500-2019-00033
• 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: 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2000
• Device Catalogue Number: 2M30404
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NA.; NA.
• Patient Outcome(s): Life Threatening