MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH - AT SENSIS HEMO LOW; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number 6634633

Device Problem Disconnection (1171)

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

Event Date 05/30/2020

Event Type  malfunction  

Manufacturer Narrative

Siemens is conducting a thorough investigation of the reported events.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed upon completion of the investigation.

Event Description

It was reported to siemens that a failure, "dmc monitor was dark" occurred during an emergency procedure.The procedure was continued and finished at another hospital.We are unaware of any impact to the state of health of the patient involved.Siemens has requested additional information in order to conduct an investigation of the reported event.Dmc = dialog monitor computer.

Manufacturer Narrative

Our experts conducted an investigation of the reported issue.No log files were available for this investigation and the defective part was not returned for detailed analysis.During the investigation siemens local service engineer checked the concerned system and found that the mainboard of the dialog monitor computer (dmc) was defective.The engineer found a defective capacitor on the motherboard.The motherboard was replaced; following the replacement the system recovered and works as intended.According to our experts, the capacitor got defective due to aging reasons.A general systematic error has not been identified.

• Brand Name: SENSIS HEMO LOW
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH - AT; siemensstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 10166930
• MDR Text Key: 195536353
• Report Number: 3004977335-2020-32193
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• PMA/PMN Number: K150493
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6634633
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1