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

Catalog Number 2M30404

Device Problem Break (1069)

Patient Problems Burn(s) (1757); Swelling (2091)

Event Date 07/02/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during use of a babytherm 8004 one of the halogen lamps suddenly broke.The patient suffered from several burn blisters.Reportedly there was no permanent injury.

Manufacturer Narrative

In addition to the damaged bulb 2 other ones that had been assembled in the same device were returned for investigation.The investigation was also carried out based on the provided photos and the reported information.The radiation output of the two undamaged bulbs measured and found to be 60% and 75% lower compared to new bulbs.As the output normally falls by 20-25% per 1000 operating hours, this indicates that the bulbs were being used for approximately 2500 ¿ 3500hours.The babytherm instructions for use advise the user to replace the bulbs after 1000 operating hours.Consequently, the device features an hour meter which counts the operating hours of the phototherapy bulbs.This hour meter was checked and showed 3385hours which goes along with the above mentioned reduced radiation output.Following the instructions for use by replacing the bulbs after 1000 operating hours would have prevented from this event.Usage of the bulb for a longer period than 1000 hours increases the risk of a bulb failure.A failure of a bulb usually only results in a loss of radiation without any mechanical damage.The reported symptom of a broken bulb is extremely rare.Since the year 2001 only one similar case with a broken bulb has been reported to draeger.However in that case that case the root cause was another kind of user error (the ventilation slots were covered).Thus, this particular case can be classified as a single event.

Event Description

Please see 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
• Manufacturer Contact: sonja hillmer ; moislinger allee 53-55; lübeck 23542 ; GM 23542 ; 4518822868
• MDR Report Key: 5789798
• MDR Text Key: 49389050
• Report Number: 9611500-2016-00201
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K971198
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 09/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2016
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2012
• 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