MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. STREAMLAB

Model Number STREAMLAB

Device Problem Labelling, Instructions for Use or Training Problem (1318)

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

Event Date 07/27/2018

Event Type  malfunction  

Manufacturer Narrative

Siemens was notified by the original equipment manufacturer for streamlab that a pacemaker safety label (implanted cardiac device) may be missing from certain streamlab systems.The potentially impacted streamlab modules are the core unit / lynx with input output module (iom) and refrigerated storage module.Siemens was further informed that the minimum safety distance from devices emitting a magnetic field should be increased to 200 millimeters (7.87 inches).Siemens has issued an urgent medical device correction titled aptio® automation streamlab® automation some modules missing pacemaker warning labels ((b)(4)) and an urgent field safety notification titled aptio® automation streamlab® automation some modules missing pacemaker warning labels ((b)(4)) to all affected customers.

Event Description

Siemens was notified by the original equipment manufacturer (oem) for sreamlab that an ongoing investigation has determined that a pacemaker safety label (implanted cardiac device) may be missing from certain streamlab systems.Siemens was further informed that the minimum safety distance from devices emitting a magnetic field should be increased to 200 millimeters (7.87 inches).There are no known reports of adverse health consequences due to the missing pacemaker safety label or the increase of the minimum safety distance.

• Brand Name: STREAMLAB
• Type of Device: STREAMLAB
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): INPECO S.P.A; via givoletto 15; italy registration #: 30055092; 10040 val della torre (torino), ; IT
• Manufacturer Contact: karl aebig ; 511 benedict ave; tarrytown, NY 10591 ; 9145243102
• MDR Report Key: 7786204
• MDR Text Key: 117299002
• Report Number: 2517506-2018-00449
• Device Sequence Number: 1
• Product Code: LXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/15/2018

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: STREAMLAB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/27/2018
• Initial Date FDA Received: 08/15/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 2517506-08/15/2018-007-C
• Patient Sequence Number: 1