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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 Unknown (for use when the patient's condition is not known) (2202)
Event Date 01/24/2014
Event Type  Injury  
Event Description
It was reported by the customer the fms solo+ unit was being used in a rotator cuff procedure and stopped working in the middle of the case.The customer didn't have another unit and the case was aborted.No device will be returned for analysis at this time.Follow-up information was received via telephone from the customer's biomed engineer on (b)(4) 2014.The biomed stated that the device had not been used by the customer for about six months and it had been set up incorrectly for this procedure.The biomed stated that the there was nothing wrong with the pump or its tube sets.The biomed stated that he did not have any information regarding adverse patient consequences or the patient's condition.
 
Manufacturer Narrative
The complaint device is not being returned to mitek for evaluation.Follow up information received form the hospital biomed suggests that the device is question was set up incorrectly during the procedure.There was no indication of device performance failure.Therefore, this failure can be attributed to user error.At this time, 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.
 
Manufacturer Narrative
The complaint device is not being returned to mitek for evaluation.Follow up information received form the hospital biomed suggests that the device is question was set up incorrectly during the procedure.There was no indication of device performance failure.Therefore, this failure can be attributed to user error.At this time, 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 the fms solo+ unit was being used in a rotator cuff procedure and stopped working in the middle of the case.The customer didn't have another unit and the case was aborted.No device will be returned for analysis at this time.Follow-up information was received via telephone from the customer's biomed engineer on 2-27-14.The biomed stated that the device had not been used by the customer for about six months and it had been set up incorrectly for this procedure.The biomed stated that the there was nothing wrong with the pump or its tube sets.The biomed stated that he did not have any information regarding adverse patient consequences or the patient's condition.
 
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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
ni
raynham MA 02767
Manufacturer Contact
siri belur
325 paramount drive
quality department
raynham, MA 02767
8003824682
MDR Report Key3759276
MDR Text Key16804955
Report Number1221934-2014-00141
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
Reporter Occupation Health Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 01/27/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number284590
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date01/27/2014
Event Location Hospital
Date Report to Manufacturer01/27/2014
Date Manufacturer Received01/27/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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