MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. CALL-BALL; SYSTEM, IMAGE PROCESSING

Device Problems No Audible Alarm (1019); Kinked (1339)

Patient Problem No Information (3190)

Event Date 03/25/2016

Event Type  malfunction  

Event Description

Our hospital was reviewing a patient concern.A patient reported that when they squeezed the ball, there was no response from the control room.A pneumatic call-ball attached to an air filled cord is a connection to an external audio system and light system.When the ball is squeezed, an audible sound/ alert is sounded, heard and visualized as a light in the mri control room.The call-ball is an air filled bulb-ball that is connected to a flexible tubing which utilizes a male connector to a female port.This air filled tubing is connected to the foot of the mri patient table.The patient activates the system by squeezing the call-ball which alerts the technologist in the control area with both visual and audible alarm and then this has to be deactivated by the mri technologist.We found that if the cord is crimped in anyway or closure of the air filled tubing or failure to squeeze the ball with sufficient force deactivates the feature and no sound or light is seen.We are reporting this as a safety concern.

• Brand Name: CALL-BALL
• Type of Device: SYSTEM, IMAGE PROCESSING
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 51 valley stream parkway; malvern PA 19355
• MDR Report Key: 6804455
• MDR Text Key: 83364197
• Report Number: 6804455
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/22/2016

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: Other
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/22/2016
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/22/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1