• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC CART 9734056 S7 STAFF SHRT 100-120V INTL INSTRUMENT, STEREOTAXIC

  • 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
 

MEDTRONIC NAVIGATION, INC CART 9734056 S7 STAFF SHRT 100-120V INTL INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9734056
Device Problem Audible Prompt/Feedback Problem (4020)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/01/2021
Event Type  malfunction  
Manufacturer Narrative
Continuation of concomitant products: information references the main component of the system. Other relevant device(s) are: product id: 9733437, serial/lot #:(b)(4), ubd: unknown, udi#: (b)(4). This event took place in (b)(6). A medtronic representative visited the site to evaluate the equipment. Hardware parts were replaced. Codes b01, c07, and d02 are applicable. The returned psu had no noise when powered up on the test bench. A check of the event log did not show any adverse events. However, the psu did fail an accuracy test (aak) at. 40 mm with a passing threshold of. 35 mm. Codes b01, c13, and d02 are applicable. The returned scu was analyzed, but no failures were found. Codes b01, c19, and d14 are applicable. The returned ups was analyzed, but no failures were found. Codes b01, c19, and d14 are applicable. The returned axiem was analyzed, but no failures were found. Codes b01, c19, and d14 are applicable. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information while servicing the imaging system. It was observed that a noise was generated during inspection of the system. No patient involvement was reported. Additional information was received. It was reported that there was no indication as to where the noise was coming from.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCART 9734056 S7 STAFF SHRT 100-120V INTL
Type of DeviceINSTRUMENT, STEREOTAXIC
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer Contact
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key11739638
MDR Text Key248643412
Report Number1723170-2021-01138
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 04/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9734056
Device Catalogue Number9734056
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/09/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-