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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS ELECTRONICS NEDERLAND B.V. ACHIEVA 1.5T NEW
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PHILIPS ELECTRONICS NEDERLAND B.V. ACHIEVA 1.5T NEW Back to Search Results
Model Number ACHIEVA 1.5T
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Partial thickness (Second Degree) Burn (2694)
Event Date 05/05/2021
Event Type  Injury  
Event Description
Philips received a report on a heating incident on an achieva 1.5t mr system.More than 1 hour after the examination a 3 cm large blister was observed on the groin of the patient.
 
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Brand Name
ACHIEVA 1.5T NEW
Type of Device
ACHIEVA 1.5T NEW
Manufacturer (Section D)
PHILIPS ELECTRONICS NEDERLAND B.V.
veenpluis 6
best 5684 PC
NL  5684 PC
Manufacturer (Section G)
PHILIPS ELECTRONICS NEDERLAND B.V.
veenpluis 6
best 5684 PC
NL   5684 PC
Manufacturer Contact
dusty leppert
222 jacobs st
cambridge, MA 02141
6172455900
MDR Report Key11990206
MDR Text Key255921293
Report Number3003768277-2021-10027
Device Sequence Number1
Product Code LNH
UDI-Device Identifier00884838004108
UDI-Public884838004108
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K063559
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberACHIEVA 1.5T
Device Catalogue Number781296
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date05/19/2021
Date Manufacturer Received05/19/2021
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
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age75 YR
Patient Weight60
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