MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH SENIS VIBE HEMO LOW; PROGRAMMABLE DIAGNOSTIC COMPUTER

Model Number 6634633

Device Problems Electrical /Electronic Property Problem (1198); Power Problem (3010)

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

Event Date 07/08/2021

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.Internal id # (b)(4).

Event Description

It was reported to siemens that a malfunction occurred while operating the sensis vibe hemo low system.During an interventional procedure, the uninterruptible power supply (ups) started beeping until the sensis vibe hemo stopped working.The procedure was continued and completed on 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 conduct an investigation of the reported event.The reported event occurred in (b)(6).

Manufacturer Narrative

Siemens has completed an investigation of the reported event.Assessment does not indicate a system failure or malfunction and no non-conformity was identified.The investigation did not identify a clear and verifiable cause of the fault.It was reported that the uninterruptible power supply (ups) started beeping for an unknown reason, usually indicating a loss of main power.This is expected and normal behavior when the power supply has failed.To date, the customer has not been able to confirm whether this was the case on site.It would also be conceivable that the voltage supply to the ups was not guaranteed at this time.In this case, a power supply plug that was not carefully plugged into the ups is plausible.However, this has also not yet been confirmed by the customer.The operating instructions explain accordingly that the user should shut down the system immediately in the event of a power failure, especially since the ups can only maintain the voltage supply for a limited time.The ups in question was inspected on site by the local service department, but no faults were found.Although the system including the batteries apparently functioned as specified, the complete ups was replaced as a precaution.The occurrence rate of the error pattern and the spare parts consumption were reviewed.Any accumulation of errors or even a systematic error that would lead to corrective action could not be determined by the investigation.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: SENIS VIBE HEMO LOW
• Type of Device: PROGRAMMABLE DIAGNOSTIC COMPUTER
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 12188851
• MDR Text Key: 262211533
• Report Number: 3004977335-2021-88365
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 04056869010199
• UDI-Public: 04056869010199
• 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: 07/19/2021

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: 6634633
• Initial Date Manufacturer Received: 07/08/2021
• Initial Date FDA Received: 07/19/2021
• Supplement Dates Manufacturer Received: 09/29/2021
• Supplement Dates FDA Received: 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other