MAUDE Adverse Event Report: SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD. SOMATOM GO.NOW (BR); SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number 11061612

Device Problem Use of Device Problem (1670)

Patient Problem Laceration(s) (1946)

Event Date 04/10/2022

Event Type  Injury  

Manufacturer Narrative

Udi is unknown for this model which is sold in (b)(6).The udi for somatom go.Now system in the us by the same manufacturer is (b)(4).Siemens completed an investigation regarding the reported event.A siemens customer service engineer (cse) examined the complaint ct system and confirmed it functioned within specifications.The cse repositioned the plexi-ring after the reported event and has ordered a new plexi-ring to be installed once received.The patient had a clinical condition (spastic neuropathy with intermittent spasms and bent lower limbs) that limited positioning on the patient table; however, the technician did not use restraint straps to properly fixate the patient and did not monitor the status of the patient during the examination.In the somatom go.Now instructions for use (ifu), doc.Id: (b)(4), it is clearly stated on pages 32-33 to fixate and monitor the patients during examination.The root cause of this event is user misuse (failure to follow instructions).

Event Description

It was reported to siemens that a (b)(6) patient, with atrophy (spastic neuropathy), lower limbs remaining bent, and intermittent spasms, sustained injury during the ct examination.The patient was limited regarding positioning on the ct system patient table due to his clinical condition.At the start of the ct examination, the patient had an involuntary contraction and hit his knee on the plexi-ring portion of the ct system, damaging the flexible material of the ring.The damaged plexi-ring in combination with the table movement resulted in abrasions to the patient's arm and knee.The patient's injuries were treated at the hospital with wound dressings and analgesics.The patient's condition was then stabilized.The technician did not use fixation straps to restrain the patient and did not monitor the status of the patient during the examination.This report has been submitted with an abundance of caution.The reported event occurred in (b)(6).

• Brand Name: SOMATOM GO.NOW (BR)
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD.; 278 zhou zhu rd.; shanghai, 20131 8; CH 201318
• Manufacturer (Section G): SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD.; 278 zhou zhu rd.; shanghai, 20131 8; CH 201318
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 14240112
• MDR Text Key: 290532864
• Report Number: 3003202425-2022-24338
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K211373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 04/28/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: 11061612
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/13/2022
• Initial Date FDA Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 94 YR
• Patient Sex: Male
• Patient Weight: 41 KG