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

Model Number 6634633

Device Problem Decoupling (1145)

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

Event Date 06/28/2020

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 follow-up report will be filed upon completion of the investigation.

Event Description

It was reported to siemens that an error occurred while using the axiom sensis hemo low system.During an emergency procedure, the user reports the blood pressure curve is not stable and sometimes gone.The procedure was continued and finished using an alternate system.We are unaware of any impact to the state of health of the patient involved.Siemens has requested additional information in order to investigate of the reported event.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The root cause was determined to be a third-party manufacturer hardware error.The investigation showed that the problem was a hardware fault of a third-party manufacturer.The so-called "st.Jude's" cable (now abbott) was defective, which meant that the blood pressure could no longer be reliably measured and displayed.The local service technician replaced the operator's own cable and the system works as specified.A possible system error of the axiom sensis, hemo low was therefore not present.Afterwards the system worked as specified and the error has not been reported again.After detailed investigation, the incident is not classified as a reportable event as neither serious injury, death nor an unexpected prolonged hospitalization of the patient or any other person occurred or could be expected.

• Brand Name: AXIOM 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: 10289417
• MDR Text Key: 220728438
• Report Number: 3004977335-2020-36638
• 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: company representative,foreig
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 07/17/2020

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: No Information
• Device Model Number: 6634633
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/01/2020
• Initial Date FDA Received: 07/17/2020
• Supplement Dates Manufacturer Received: 08/20/2020
• Supplement Dates FDA Received: 08/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1