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

Model Number MS26800

Device Problem Fire (1245)

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

Event Type  malfunction  

Event Description

It was reported: fire incident occurred to one of the draeger central station at (b)(6) hospital (b)(6) area.The unit model: ms26800 sn: (b)(4) draeger id: (b)(4).The incident happened this morning around 6:50am inside (b)(6) area, little fire and smoke noticed by the staff near the nurse station.Staff managed to put the little fire down and removed the keyboard from site, central system is tested by our engineers and working alright and the effected keyboard is replaced with a temporarily keyboard.No adverse patient impacts was reported.

Manufacturer Narrative

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

Event Description

It was reported: fire incident occurred to one of the (b)(6) hospital.The unit model: ms26800 sn: (b)(6) draeger id: 1029093110.The incident happened this morning around 6:50am inside zone 3 area, little fire and smoke noticed by the staff near the nurse station.Staff managed to put the little fire down and removed the keyboard from site, central system is tested by our engineers and working alright and the effected keyboard is replaced with a temporarily keyboard.No adverse patient impacts was reported.

Manufacturer Narrative

The reported issue was confirmed but a precise root cause could not be determined.Upon review of the complaint photos and the keyboard itself, the damage was to the cable connecting the keyboard to the computer via usb.The cable damage was consistent with an internal wiring issue.A replacement keyboard (keybrd spillproof en - ms22288) will be sent to the customer.This is an isolated case.

• Brand Name: INFINITY CENTRAL STATION
• Type of Device: PHYSIOLOGICAL MONITORING SYSTEMS
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC; 6 tech drive; andover MA
• Manufacturer (Section G): DRAEGER MEDICAL SYSTEMS, INC; 6 tech drive; andover MA
• MDR Report Key: 12847224
• MDR Text Key: 282126783
• Report Number: 1220063-2021-00031
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04049098001878
• UDI-Public: 04049098001878
• Combination Product (y/n): N
• PMA/PMN Number: K061379
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MS26800
• Device Catalogue Number: MS26800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2021
• Initial Date FDA Received: 11/19/2021
• Supplement Dates Manufacturer Received: 10/21/2021
• Supplement Dates FDA Received: 06/29/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/04/2019
• 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