MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC INFINITY CENTRAL STATION; PHYSIOLOGICAL MONITORING SYSTEMS

Model Number MS23561

Device Problems Fire (1245); Melted (1385); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/16/2020

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be submitted upon completion of this investigation.

Event Description

It was reported that: during maintenance at the (b)(6), three ups (apc-620) caught fire when they were switched on again.The flames came out of the left and right side of the ups, the fire did not go out by itself.Maintenance was then suspended on other ups.The university technicians knew the phenomenon and explain it as follows: the motherboard is directly under the metal case with a distance of about 6-8mm.The pcb is installed in such a way that the pins of the components point to the metal case.To prevent the pcb from touching the case, rubber feet are glued to the pcb.These have now become liquid after 6-8 years and have melted.The circuit board bends due to the heat.A part of the board now touches the metal case from the inside.However, the damage only occurs after switching on again, since this part is not under tension during operation.Unfortunately, the material is no longer available.Additional information received: the fires were small and isolated, easy to put out.The fires were extinguished by blowing on them.The power supplies were discarded and replaced with new ones.This case is regarding the uninterruptable power supply (ups) used with the infinity central station (ics).No patient involvement was reported.

Event Description

It was reported that: during maintenance at the university of freiburg, three ups (apc-620) caught fire when they were switched on again.The flames came out of the left and right side of the ups, the fire did not go out by itself.Maintenance was then suspended on other ups.The university technicians knew the phenomenon and explain it as follows: the motherboard is directly under the metal case with a distance of about 6-8mm.The pcb is installed in such a way that the pins of the components point to the metal case.To prevent the pcb from touching the case, rubber feet are glued to the pcb.These have now become liquid after 6-8 years and have melted.The circuit board bends due to the heat.A part of the board now touches the metal case from the inside.However, the damage only occurs after switching on again, since this part is not under tension during operation.Unfortunately, the material is no longer available.Additional information received: the fires were small and isolated, easy to put out.The fires were extinguished by blowing on them.The power supplies were discarded and replaced with new ones.This case is regarding the uninterruptable power supply (ups) used with the infinity central station (ics).No patient involvement was reported.

Manufacturer Narrative

Due to a technical issue with our internal emdr system we submitted for the form fda 3500a an incorrect value, device not returned to manufacturer.

Manufacturer Narrative

Additional information was provided noting that the fires were small, isolated and easy to put out however, did not self-extinguish, the site technician blew them out.The site technician concluded the cause was that the rubber feet that separate the pcba pins from touching the metal case were degraded and the pcba¿s were bent from heat damage resulting in a short circuit/fire.The image provided showed the underneath of a ups main pcba with a pin (of component hs2) with visible black charring indicative of a electrical shorting.A review of the complaint database showed no similar cases relating to ups bent mainboards or degradation of the grommets/feet.It was confirmed that the power supplies were not used in direct sunlight, in contact with fluids, used where there is excessive dust or humidity, near open windows or doors, air vents are not blocked and there is adequate space for proper ventilation as indicated in the instructions for use.The power supplies were replaced and no further issues have been reported.The involved power supplies were scrapped/not available to be returned for further analysis.Therefore, precise root cause cannot be determined.This is an isolated case.

Event Description

It was reported that: during maintenance at (b)(6), three ups (apc-620) caught fire when they were switched on again.The flames came out of the left and right side of the ups, the fire did not go out by itself.Maintenance was then suspended on other ups.The university technicians knew the phenomenon and explain it as follows: the motherboard is directly under the metal case with a distance of about 6-8mm.The pcb is installed in such a way that the pins of the components point to the metal case.To prevent the pcb from touching the case, rubber feet are glued to the pcb.These have now become liquid after 6-8 years and have melted.The circuit board bends due to the heat.A part of the board now touches the metal case from the inside.However, the damage only occurs after switching on again, since this part is not under tension during operation.Unfortunately, the material is no longer available.Additional information received: the fires were small and isolated, easy to put out.The fires were extinguished by blowing on them.The power supplies were discarded and replaced with new ones.This case is regarding the uninterruptible power supply (ups) used with the infinity central station (ics).No patient involvement was reported.

• Brand Name: INFINITY CENTRAL STATION
• Type of Device: PHYSIOLOGICAL MONITORING SYSTEMS
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC; 6 tech drive; andover MA 01810 2434
• Manufacturer (Section G): DRAEGER MEDICAL SYSTEMS, INC; 6 tech drive; andover MA 01810 2434
• MDR Report Key: 11834399
• MDR Text Key: 253816257
• Report Number: 1220063-2021-00016
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• PMA/PMN Number: K061379
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MS23561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2013
• 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
• Treatment: NA.; NA.; NA.