MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH YSIO MAX; SYSTEM, X-RAY, STATIONARY

Model Number	10762470
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	06/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturers preliminary analysis: based on the available information, it was determined that a system malfunction did not occur.The handles of the bucky wall stand are not intended to hold the full weight of a patient.There is a note in the system operator manual to make sure that the detector unit is not mechanically overloaded by a patient, for example by the patient sitting, falling, or leaning on it.The overload caused the brakes of the detector unit to fail so that it could slide down to the floor.Initial corrective actions/preventive actions implemented by the manufacturer: based on the available information, no system malfunction was determined to have occurred.There is a note in the operator manual to make sure that the detector unit is not mechanically overloaded by a patient.No general problem was determined for the installed base, no corrective or preventive actions were initiated.A supplemental report will not be forthcoming for this event.Internal id# (b)(4).
Event or Problem Description
It was reported the patient applied his full weight on the handles of the bucky wall stand in preparation for a knee examination.It is understood that the stretch grips are meant for use in this case.The full weight of the patient on the handles led to the brakes of the detector unit failing and the unit sliding onto the floor.This event resulted in the operator's finger being broken while she was squatting on the floor to adjust the system for the exposure.The operator suffered a fracture of the terminal phalanx of the fourth finger and a finger splint was applied.After this, she was able to resume work.No injury to the patient was communicated.It is assumed that in worst-case scenario this issue might lead to a moderate injury to the patient or user.The operator's broken finger is classified as a moderate injury; therefore, the event is being reported with an abundance of caution.The reported event occurred in (b)(6).
Additional Manufacturer Narrative
H11: corrected data b1: product problem was added.H6: investigation codes were corrected.H10: it was initially determined based on the information received and the manufacturer's preliminary analysis that a system malfunction did not occur.The handles of the bucky wall stand are not intended to hold the full weight of a patient.There is a note in the system operator manual to make sure that the detector unit is not mechanically overloaded by a patient, for example by the patient sitting, falling, or leaning on it.The overload caused the brakes of the detector unit to fail so that it could slide down to the floor.Additional investigation revealed that the root cause of the incident was not only the fact that the patient had placed his full weight on the handles of the bucky leading to the unit sliding to the floor, but that also the functionality of the brakes was impacted due to contamination found on the brake pads.An oil film of typical mineral oil was found.Due to this contamination the specified holding force of the unit with active brakes of 250n was not met but was below 200n.Instead of the specified slipping torque of 2.7 ± 0.3nm, only 2.0 nm was measured.Therefore, when the patient exerted his weight on the handles, it did not hold position as expected.The braking force was recorded to be 370n when the unit left the factory.According to the maintenance instructions the braking force must be checked.The contamination must have taken place between the last maintenance and the time of the incident.It cannot be determined in retrospect how the contamination occurred.There is information in the system maintenance instructions stating no lubrication of the motor cpl or ball bearings may be carried out.Internal id# pm(b)(4).

• Brand Name: YSIO MAX
• Common Device Name: SYSTEM, X-RAY, STATIONARY
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemensstr. 1 or rittigfeld 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 14840355
• Report Number: 3004977335-2022-33072
• Device Sequence Number: 14048915
• Product Code: KPR
• UDI-Device Identifier: 04056869004273
• UDI-Public: 04056869004273
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K181279
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 10762470
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2022
• Supplement Date Received by Manufacturer: 11/08/2022
• Initial Report FDA Received Date: 06/28/2022
• Supplement Report FDA Received Date: 11/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown