MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. APTIO AUTOMATION

Model Number APTIO AUTOMATION

Device Problem Mechanical Problem (1384)

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

Event Date 07/29/2020

Event Type  malfunction  

Manufacturer Narrative

The customer contacted siemens to report that the operator of an aptio automation system cut his finger on the shutter mechanism of the storage and retrieval module (srm).The operator put a band aid on the cut and did not seek additional medical treatment.The cause of the cut to the finger is an unintented use error of the operator pushing the rack back into the srm.The system is performing within specifications.No further evaluation of the system is needed.

Event Description

The customer contacted siemens to report that the operator of an aptio automation system cut his finger on the shutter mechanism of the storage and retrieval module (srm).There are no known reports of patient intervention or adverse health consequences due to the cut on the finger.

• Brand Name: APTIO AUTOMATION
• Type of Device: APTIO AUTOMATION
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark, de
• Manufacturer (Section G): INPECO S.P.A; via torraccia 26; registration #: 3010825766; novazzano, 6883 ; SZ 6883
• Manufacturer Contact: karl aebig ; 511 benedict ave; tarrytown, ny ; 5243102
• MDR Report Key: 10439545
• MDR Text Key: 204231232
• Report Number: 2517506-2020-00260
• Device Sequence Number: 1
• Product Code: LXG
• UDI-Device Identifier: 00630414596754
• UDI-Public: 00630414596754
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/21/2020

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: APTIO AUTOMATION
• Device Catalogue Number: 10713760
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/30/2020
• Initial Date FDA Received: 08/21/2020
• 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: N
• Patient Sequence Number: 1