MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION EXL WITH LM

Model Number DIMENSION EXL WITH LM

Device Problem Device Handling Problem (3265)

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

Event Date 09/04/2018

Event Type  malfunction  

Manufacturer Narrative

The customer service engineer (cse) sustained an injury to the knee while servicing a dimension exl instrument.Siemens is investigating the issue.

Event Description

A siemens customer service engineer (cse) sustained an injury to the knee while cleaning the debris and cables behind a dimension exl with lm instrument.The cse injured his knee on a small sample container (ssc) when he kneeled onto the ssc.The cse's injury resulted in an infection, swelling and pain.The cse also sought medical treatment and was prescribed antibiotics.The doctor advised the cse to ice the knee and to elevate the leg.There were no reports of adverse health consequences due to the cse's injury to the knee.

Manufacturer Narrative

Siemens filed the initial mdr (b)(6) 2018.Additional information (8-oct-2018): the customer service engineer (cse) returned to the customer site and examined the area behind the instrument to ensure that no further hazards were present.The instrument is performing within specifications.No further evaluation of the device is required.H6 conclusion code has been updated to reflect the additional information.

• Brand Name: DIMENSION EXL WITH LM
• Type of Device: DIMENSION EXL WITH LM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 7918128
• MDR Text Key: 122010243
• Report Number: 2517506-2018-00558
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): N
• PMA/PMN Number: K130276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIMENSION EXL WITH LM
• Device Catalogue Number: 10486890
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1