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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS HEALTHCARE INTERA 1.5T POWER/PULSAR; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

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PHILIPS HEALTHCARE INTERA 1.5T POWER/PULSAR; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
Model Number 781105
Device Problem Temperature Problem (3022)
Patient Problem Partial thickness (Second Degree) Burn (2694)
Event Date 01/15/2019
Event Type  Injury  
Manufacturer Narrative
Based on the provided information, there is no indication of a malfunction of the mri system or coil used that contributed to the injury.The injury is consistent with injuries caused by close proximity to the magnet bore.Contributing factors are: the patient is obese.Obese persons have impaired thermoregulatory capabilities the used scan protocols with consecutive scans with a high whole body sar.
 
Event Description
Philips received a report about a heating incident with the sense spine coil on an intera 1.5t mri system.A female patient was positioned head first supine to undergo a spine examination with the sense spine coil.Four hours after the examination, the patient reported skin reddening with 3 blisters on the right outer thigh.
 
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Brand Name
INTERA 1.5T POWER/PULSAR
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
Manufacturer (Section G)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
dusty leppert
veenpluis 4-6
p.o. box 10.000
best 5680 -DA
NL   5680 DA
MDR Report Key8309875
MDR Text Key135147270
Report Number3003768277-2019-00008
Device Sequence Number1
Product Code LNH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K001796
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/16/2019
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 Number781105
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/16/2019
Initial Date FDA Received02/06/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/13/2002
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 Age41 YR
Patient Weight155
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