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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK MITEK FMS; FMS EQUIPMENT SYSTEMS
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DEPUY MITEK MITEK FMS; FMS EQUIPMENT SYSTEMS Back to Search Results
Catalog Number 284590
Device Problem Unknown (for use when the device problem is not known) (2204)
Patient Problem Extravasation (1842)
Event Date 11/13/2014
Event Type  Injury  
Event Description
It was reported by the customer that the device overfilled the patient's shoulder and that the pressure reading did not change.The case was aborted and rescheduled.There was no patient consequence.Device will be returned and replaced.
 
Manufacturer Narrative
Attempts have been made to retrieve additional information about the event and device.The additional information will reportedly be forwarded to depuy mitek; however, it is not known if it will be received within the 30 day reporting requirement, therefore, depuy mitek would like to file this initial medwatch report at this time.When and if additional information is received it will be reflected in a follow-up medwatch report.In process.
 
Manufacturer Narrative
The unit was evaluated and the reason for return : "device overfilled the patient's shoulder and the pressure reading did not change" could not be duplicated.The unit passed all diagnostic tests, functional tests, and is fully operational.Replaced crack irrigation safety cover.A review into the complaints system revealed two dissimilar complaints in the past for this device.At this point, no further action is warranted.However, depuy mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.
 
Event Description
It was reported by the customer that the device overfilled the patient's shoulder and that the pressure reading did not change.The case was aborted and rescheduled.There was no patient consequence.Device will be returned and replaced.
 
Manufacturer Narrative
Attempts have been made to retrieve additional information about the event and device.The additional information will reportedly be forwarded to depuy mitek however it is not known if it will be received within the 30 day reporting requirement, therefore depuy mitek would like to file this initial medwatch report at this time.When and if additional information is received it will be reflected in a follow-up medwatch report.
 
Event Description
It was reported by the customer that the device overfilled the patient's shoulder and that the pressure reading did not change.The case was aborted and rescheduled.There was no patient consequence.Device will be returned and replaced.
 
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Brand Name
MITEK FMS
Type of Device
FMS EQUIPMENT SYSTEMS
Manufacturer (Section D)
DEPUY MITEK
325 paramount drive
quality department
raynham MA 02767
Manufacturer (Section G)
DEPUY MITEK
325 paramount drive
na
raynham MA 02767
Manufacturer Contact
david primmerman
325 paramount drive
quality department
raynham, MA 02767
8003824682
MDR Report Key4304445
MDR Text Key5194100
Report Number1221934-2014-00543
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K002040
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative,Distributor
Reporter Occupation Biomedical Engineer
Remedial Action Other
Type of Report Initial,Followup,Followup
Report Date 11/13/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number284590
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/26/2014
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/13/2014
Distributor Facility Aware Date11/13/2014
Event Location Hospital
Date Report to Manufacturer11/13/2014
Date Manufacturer Received11/13/2014
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;
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