MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC INFINITY ACUTE CARE SYSTEM (M540); PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT

Model Number	MS25510
Medical Device Problem Code	Flare or Flash (2942)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of this investigation.
Event or Problem Description
It was reported that the infinity p2500 power supply caused a short circuit, as a result of which the power briefly failed in the affected room, sparks and small amounts of smoke were noted.No adverse patient impact was reported.The power supply was immediately taken out of service, dismantled for further investigation and secured so that the device can be sent in for closer examination.A new power supply unit has already been installed at the customer's site.The infinity acute care system (iacs) includes an infinity medical cockpit paired with an infinity m540 bedside monitor.The infinity p2500 power supply (ms22277, serial#: (b)(4) is the dedicated power source and networking hub for the infinity m540 patient monitor and infinity medical cockpit.
Event or Problem Description
It was reported that the infinity p2500 power supply caused a short circuit, as a result of which the power briefly failed in the affected room, sparks and small amounts of smoke were noted.No adverse patient impact was reported.The power supply was immediately taken out of service, dismantled for further investigation and secured so that the device can be sent in for closer examination.A new power supply unit has already been installed at the customer's site.The infinity acute care system (iacs) includes an infinity medical cockpit paired with an infinity m540 bedside monitor.The infinity p2500 power supply (ms22277, serial # (b)(6)) is the dedicated power source and networking hub for the infinity m540 patient monitor and infinity medical cockpit.
Additional Manufacturer Narrative
The power supply was received at draeger for analysis.Visual inspection showed no obvious signs of damage.The device was manufactured on 05may2014, making it over 8 years old.When plugged in, the power supply failed to power on.Upon opening the power supply, root cause was identified as a shorted electrical component.Due to the resulting damage to surrounding components on the board, the specific component that failed cannot be identified.The singe pattern found does not show a pathway escaping the internal enclosure of the circuit board.As the unit was over 8 years old at the time of the component failure, this is not considered an early failure or a design issue.Review of the complaint database shows this as an isolated case.H3 other text : see h10.

• Brand Name: INFINITY ACUTE CARE SYSTEM (M540)
• Common Device Name: PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT
• 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: 15530101
• Report Number: 1220063-2022-00017
• Device Sequence Number: 14086582
• Product Code: MHX
• UDI-Device Identifier: 04049098054409
• UDI-Public: 04049098054409
• Combination Product (Y/N): N
• PMA/510(K) Number: K113798
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2022

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
• Operator of Device: Health Professional
• Device Model Number: MS25510
• Device Catalogue Number: MS22277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/26/2022
• Supplement Date Received by Manufacturer: 12/02/2022
• Initial Report FDA Received Date: 10/03/2022
• Supplement Report FDA Received Date: 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown