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: PHILIPS ULTRASOUND, INC; 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, INC; TRANSDUCER, ULTRASONIC, DIAGNOSTIC Back to Search Results
Lot Number B0TX6C
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
The customer contacted philips for assistance with a probe not articulating properly.No patient injury occurred.
 
Manufacturer Narrative
The procedure in progress was completed successfully using the same transducer with no harm to the patient.Evaluation of the transducer will be included in a follow up report upon its return.
 
Manufacturer Narrative
The failed transducer was returned to the manufacturer for evaluation.The investigation concluded that the device¿s articulation was performing as designed.The customer¿s reported problem could not be reproduced.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of Device
TRANSDUCER, ULTRASONIC, DIAGNOSTIC
Manufacturer (Section D)
PHILIPS ULTRASOUND, INC
22100 bothell everett highway
bothell WA 98021
Manufacturer Contact
kim dashen
22100 bothell everett highway
bothell, WA 98021
4254877000
MDR Report Key4850663
MDR Text Key5871653
Report Number3019216-2015-00034
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,health professional
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 05/26/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot NumberB0TX6C
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/26/2015
Initial Date FDA Received06/17/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/12/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-