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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS ELECTRONICS NEDERLAND B.V. ACHIEVA 1.5T INITIAL SYSTEMS

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PHILIPS ELECTRONICS NEDERLAND B.V. ACHIEVA 1.5T INITIAL SYSTEMS Back to Search Results
Model Number ACHIEVA 1.5T INITIAL SYSTEMS
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Partial thickness (Second Degree) Burn (2694)
Event Date 12/24/2021
Event Type  Injury  
Event Description
Philips received a report on a heating incident on an achieva 1.5t mr system.A female patient was positioned head first supine to undergo a mrcp/liver examination with the sense cardiac coil.During the examination a heating sensation was experienced and shortly after the examination blisters appeared on the right forearm and right side of the abdomen of the patient.
 
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Brand Name
ACHIEVA 1.5T INITIAL SYSTEMS
Type of Device
ACHIEVA 1.5T
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 Key13203158
MDR Text Key283474290
Report Number3003768277-2022-00011
Device Sequence Number1
Product Code LNH
Combination Product (y/n)N
Reporter Country CodeSF
PMA/PMN Number
K063559
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberACHIEVA 1.5T INITIAL SYSTEMS
Device Catalogue Number781178
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/24/2021
Initial Date FDA Received01/10/2022
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 Age33 YR
Patient SexFemale
Patient Weight115 KG
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