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

MAUDE Adverse Event Report: PHILIPS ULTRASOUND X8-2T TRANSDUCER, ULTRASONIC, DIAGNOSTIC

  • 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
 

PHILIPS ULTRASOUND X8-2T TRANSDUCER, ULTRASONIC, DIAGNOSTIC Back to Search Results
Model Number TRANSDUCER X8-2T
Device Problem Mechanical Jam (2983)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/23/2020
Event Type  malfunction  
Manufacturer Narrative
After a thorough inspection and testing of the suspect transducer, the philips service engineer was unable to duplicate the failure and determined it was functioning properly. The customer had also continued to use this transducer after the reported failure without any further issues. As the transducer remains in service with no return anticipated, no further failure analysis can be performed. Worked as expected during testing.
 
Event Description
A customer reported an x8-2t model transducer would not articulate with hand controls during use. There was no injury associated with this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameX8-2T
Type of DeviceTRANSDUCER, ULTRASONIC, DIAGNOSTIC
Manufacturer (Section D)
PHILIPS ULTRASOUND
22100 bothell everett highway
bothell WA 98021
Manufacturer (Section G)
PHILIPS ULTRASOUND
22100 bothell everett highway
bothell WA 98021
Manufacturer Contact
paul corrigan
22100 bothell everett highway
bothell, WA 98021
MDR Report Key11158791
MDR Text Key226550781
Report Number3019216-2021-00005
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K163120
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation Biomedical Engineer
Type of Report Initial
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTRANSDUCER X8-2T
Device Catalogue Number989605455171
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date12/23/2020
Event Location No Information
Date Manufacturer Received12/23/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/21/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-