MAUDE Adverse Event Report: DRAEGER MEDICAL GMBH SOLA 500/700; LIGHTS

Device Problems Thermal Decomposition of Device (1071); Fire (1245); Loss of Power (1475); Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/22/2015

Event Type  malfunction  

Event Description

It was reported that during the operation the light shut down and the fire alarm was triggered.After checking the or staff found smoke coming out of the power supply box.The power supply is burned.The fire was extinguished by or doctors & nurses! according to the biomedical team this is the 2nd power supply which burned within six months.

Manufacturer Narrative

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

Manufacturer Narrative

The power supply was requested for investigation and investigated in (b)(6).The power supply shows clear indication of overheating but a burn including the houses did not happen.One capacitor got warmed up, lost its electrolyte that caused a short circuit on the secondary part of the power supply.The higher current led to an additional heat for the capacitor.Finally the capacitor ignited a flame for a short time that caused the pcb to get melded.Other than reported, the fuse reacted and stopped the high current and the upcoming smoke.This is the first case of such a nature reported to drager.More than (b)(4) power supplies are in the market since several years.

• Brand Name: SOLA 500/700
• Type of Device: LIGHTS
• Manufacturer (Section D): DRAEGER MEDICAL GMBH; 53-55 moislinger allee; luebeck 23542 ; GM 23542
• Manufacturer Contact: frank calnzett ; 53-55 moislinger allee; luebeck 23542 ; GM 23542 ; 518822868
• MDR Report Key: 4788176
• MDR Text Key: 5820438
• Report Number: 9611500-2015-00063
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• PMA/PMN Number: K010724
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative,company representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2006
• 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