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

Model Number 11007641

Device Problems Loose or Intermittent Connection (1371); Use of Device Problem (1670)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 04/22/2020

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 malfunction occurred while operating the sensis vibe hemo system.During an interventional procedure, the user reported no communication to the sensis.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.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The root cause of the error described in the complaint was determined to be a damaged connector of the micropod (etco2 module).A service technician went onsite to investigate the issue.After talking with the customer, it was discovered that at some point the above mentioned connector to the hisib (hemo integrated signal input box) was hit and damaged.The customer could not provide any information regarding when this connector was hit or what it was hit by.The local service organization fixed the damaged connector of the affected system on site, corrected the pin alignment, and reconnected the micropod to the hisib.The system in question functioned normally after this and the error has not reoccurred.No parts were replaced.During this exam the damaged connector was re-inserted into the hisib and caused the hisib to lose power.According to siemens system specialists this can occur when the connector comes apart and the pins are misaligned from their correct positions, e.G.By turning the inlet of the plug with its pins around.In the case given this misalignment caused the internal circuity of the hisib to malfunction and throw continuous errors.In this state, the hisib is unable to communicate with the dmc and no vital signs can be displayed.Note: the possible hazardous situations "long term delay in the clinical procedure" or "interruption of the clinical procedure" can only occur if all 3 contributing factors (pulling the plug, damaging it and wrong re-insertion) are occurring.Therefor we've decided to inform all customers via a customer safety advisory notice (csan) to not re-insert the inlet of the plug if it is damaged.The customer has to inform the local service organization which will handle the issue.A customer safety advisory notice (csan) is planned to be released.The incident described in the adverse event was not classified as a reportable event after detailed investigation, because neither serious injury, death nor an unexpected prolonged hospitalization of the patient or any other person occurred or could be expected, since the corresponding probability according to the risk analysis is in the range of inconceivable.

• Brand Name: SENSIS VIBE HEMO
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH- AT; siemensstrasse 1; forchheim, germany 91301 ; GM 91301
• MDR Report Key: 10051256
• MDR Text Key: 191119254
• Report Number: 3004977335-2020-27702
• 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,user f
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 07/27/2020

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: Health Professional
• Device Model Number: 11007641
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/22/2020
• Initial Date FDA Received: 05/13/2020
• Supplement Dates Manufacturer Received: 07/27/2020
• Supplement Dates FDA Received: 07/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1