MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH HEMATEK 3000 SYSTEM

Model Number HEMATEK 3000 SYSTEM

Device Problem Unintended Electrical Shock (4018)

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

Event Date 11/06/2020

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc).The instrument was examined by the laboratory's in-house biomedical technician.No stray voltage was observed, and the voltage was found to be acceptable.Siemens is investigating the issue.

Event Description

The customer alleged they received an electrical shock after touching the laboratory's hematek 3000 system.The operator was not injured due to the electrical shock and did not seek medical attention.Statements and actions attributed to the customer are derived from information submitted to the siemens complaint handling system and haven't been verified.

Manufacturer Narrative

Siemens filed the initial mdr 961806-2020-00060 on 01-dec-2020.Additional information (02-dec-2020): no stray voltage was measured, and the voltage was found to be acceptable by the laboratory's in-house biomedical technician.No reoccurrence of the issue has been reported.Static discharge cannot be ruled out as a potential cause of the event.The cause of the event is unknown.The system is performing according to specifications.No further evaluation of this device is required.

• Brand Name: HEMATEK 3000 SYSTEM
• Type of Device: HEMATEK 3000 SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring- str. 76; marburg, D-350 41; GM D-35041
• MDR Report Key: 10928001
• MDR Text Key: 225139025
• Report Number: 9610806-2020-00060
• Device Sequence Number: 1
• Product Code: KPA
• Combination Product (y/n): N
• PMA/PMN Number: K771559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 12/28/2020

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: HEMATEK 3000 SYSTEM
• Device Catalogue Number: 10805311
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/06/2020
• Initial Date FDA Received: 12/01/2020
• Supplement Dates Manufacturer Received: 12/02/2020
• Supplement Dates FDA Received: 12/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1