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U.S. Department of Health and Human Services

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

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PHILIPS ELECTRONICS NEDERLAND B.V. ACHIEVA 1.5T DSTREAM Back to Search Results
Model Number SMARTPATH TO DSTREAM FOR 1.5T
Device Problems Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)
Patient Problem Partial thickness (Second Degree) Burn (2694)
Event Date 10/08/2022
Event Type  Injury  
Event Description
Philips received a report on a heating incident.Patient got a burn in abdomen and rf burn.
 
Manufacturer Narrative
Conclusion: there is no indication of a malfunction of the mr system or coils used that could have contributed to the incident.The observed blistering can be explained by the presence of the metallic fibers in the clothing as the patient was wearing silk clothing which contained metallic fibers which subsequently heated up under the influence of the rf energy.
 
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Brand Name
ACHIEVA 1.5T DSTREAM
Type of Device
ACHIEVA 1.5T DSTREAM
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 Key15595271
MDR Text Key301735220
Report Number3003768277-2022-00499
Device Sequence Number1
Product Code LNH
Combination Product (y/n)N
Reporter Country CodeIN
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,Followup
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 NumberSMARTPATH TO DSTREAM FOR 1.5T
Device Catalogue Number781260
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/08/2022
Initial Date FDA Received10/13/2022
Supplement Dates Manufacturer Received10/08/2022
Supplement Dates FDA Received11/28/2022
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 Age45 YR
Patient SexMale
Patient Weight60 KG
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