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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS HEALTHCARE ACHIEVA 1.5T NEW; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

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PHILIPS HEALTHCARE ACHIEVA 1.5T NEW; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
Model Number 781296
Device Problem Overheating of Device (1437)
Patient Problem Partial thickness (Second Degree) Burn (2694)
Event Date 09/04/2019
Event Type  Injury  
Manufacturer Narrative
The investigation is still ongoing for this event.When the investigation is completed a follow-up will sent to the fda.
 
Event Description
Philips received a report on a heating incident on an achieva 1.5t mr system.A female patient sustained a second degree injury on the back of both knees.
 
Manufacturer Narrative
Conclusion: based on the provided information and test performed on site the mr system and coil used are not suspected to have contributed to the event.The injury is consistent with heating incidents caused by contact with conductive material.In this case, the object that caused the burn was not identified.When the instructions for use are followed, such a heating incident would not be possible.Contributing factors in this case: 7 scans with high sar values (> 2 w/kg and up to 4 w/kg) were executed in a short period of time, allowing no cool down time for the patient.The total administered specific energy dose of 4.8 kj/kg exceeded the recommended limit of 3.5 kj/kg.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
 
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Brand Name
ACHIEVA 1.5T NEW
Type of Device
SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
Manufacturer (Section D)
PHILIPS HEALTHCARE
veenpluis 4-6
p.o. box 10.000
best 5680 DA
NL  5680 DA
MDR Report Key9375153
MDR Text Key167976945
Report Number3003768277-2019-00095
Device Sequence Number1
Product Code LNH
Combination Product (y/n)N
PMA/PMN Number
K063559
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 11/08/2019
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 Number781296
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/08/2019
Initial Date FDA Received11/26/2019
Supplement Dates Manufacturer Received11/08/2019
Supplement Dates FDA Received01/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age54 YR
Patient Weight65
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