Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEUSOFT MEDICAL SYSTEMS CO., LTD. NEUVIZ 64 IN; CT SCANNER
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

NEUSOFT MEDICAL SYSTEMS CO., LTD. NEUVIZ 64 IN; CT SCANNER Back to Search Results
Model Number NEUVIZ 64 IN
Device Problems Device Dislodged or Dislocated (2923); Device Fell (4014)
Patient Problems Laceration(s) (1946); Skin Tears (2516)
Event Date 09/15/2019
Event Type  malfunction  
Manufacturer Narrative
Note: we have not received the detailed information on the event, so we cannot confirm the accurate process how the event happened.We shall file a follow-up mdr to clarify the event description.We have not completed our investigation of this event, and therefore, we cannot complete at this time.We shall file a follow-up mdr at the completion of the investigation.Internal cross reference: complaint (b)(4).We submitted a hard copy of the mdr report on this event by express mail on oct 19, 2019.We submit this emdr report because our electronic submit system is just ready.
 
Event Description
The gantry mylar of neuviz 64in ct scanner dislodged and contacted a patient.Patient presented moderated lacerations in the right foot.The doctor made x-rays to the patient's foot and did skin treatment.
 
Manufacturer Narrative
The statement of the event based upon customer's address: "an elderly female patient in critical condition dependent on mechanical ventilator with chemical sedation was taken to the radiology department to perform chest ct scan.Patient was put on the couch of ct scanner, covered with a hospital sheet and was positioned feet first.The technicians left the room to carry out the diagnostic study.At the end of the scan procedure, the technicians observed the patient moving her right leg, they entered quickly thinking that the patient had woken up.Upon arrival, they observed that the gantry mylar ring had fallen, it was found over the patient's legs.The patient showed lacerations in the right foot." after the event, a new gantry mylar ring was installed and there's no similar issue was reported from this site again.Since the technicians didn't see how the gantry mylar ring was falling at the time of the event, the process of the dismount of the gantry mylar ring could not be determined exactly.The investigation and analysis by neusoft medical systems co., ltd.Suggests two possibilities for this event: the patient was not placed in the middle of the couch, so the patient's right foot might has touched and kicked off the gantry mylar ring during the couch movement at the time of the scan.The patient's clothing or the hospital sheet might has rubbed off the mylar ring from the gantry during the couch movement at the time of the scan.Those two circumstances would have the patient suffered the lacerations to her right foot by the edge of the gantry mylar ring.In the neuviz 64 en/in user manual, the technicians are asked to make sure the patient's body or related stuff such as clothing or hospital sheet not get caught in the device during positioning and scanning processes, the technicians should always following this instruction to avoid this kind of accident.
 
Event Description
The gantry mylar of neuviz 64in ct scanner dislodged and contacted a patient.Patient presented moderated lacerations in the right foot.The doctor made x-rays to the patient's foot and did skin treatment.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
NEUVIZ 64 IN
Type of Device
CT SCANNER
Manufacturer (Section D)
NEUSOFT MEDICAL SYSTEMS CO., LTD.
no.177-1 chuangxin road
hunnan district
shenyang, liaoning 11016 7
CH  110167
MDR Report Key9248671
MDR Text Key219200856
Report Number3003575350-2019-00001
Device Sequence Number1
Product Code JAK
UDI-Device Identifier06970167440022
UDI-Public(01)06970167440022(11)180328
Combination Product (y/n)N
PMA/PMN Number
K121792
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Remedial Action Repair
Type of Report Initial,Followup
Report Date 10/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/29/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberNEUVIZ 64 IN
Was Device Available for Evaluation? Yes
Date Manufacturer Received10/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age78 YR
Patient Weight75
-
-