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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL FMS VUE PUMP; DISTENSION UNIT, FLUID, ARTHROSCOPIC
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MEDOS INTERNATIONAL SàRL FMS VUE PUMP; DISTENSION UNIT, FLUID, ARTHROSCOPIC Back to Search Results
Catalog Number 284002
Device Problem Intermittent Continuity (1121)
Patient Problem Not Applicable (3189)
Event Date 10/01/2019
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).
 
Event Description
As reported by the sales rep via phone, the unit powered down while in use with a case.They were able to complete the case with a like device with a 5 minute delay to swap units out.No patient consequence.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: investigation summary: the device was received and evaluated at the service center.The reported complaint that the device powered down was confirmed.It was found that the main pcb had failed.The device had power supply failure and the fuses were defective.Also it was found that the pump had excessive flow and an internal gear was found to be worn.The defective parts were replaced and the device was tested and found to be working according to specifications.The worn gear is a result of prolonged use of the device over time.This may have caused the excessive flow with the pump.However, given the information provided we cannot discern a definitive root cause for the pcb failure.The service history has been reviewed in lieu of the device history record for this device since it was previously serviced.The device was last serviced on (b)(6)2019 and passed all functional testing before being returned to the customer.At this point in time, no corrective action is required, and no further action is warranted.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.Device history: the service history has been reviewed in lieu of the device history record for this device since it was previously serviced.The device was last serviced on (b)(6)2019 and passed all functional testing before being returned to the customer.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: d8.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.H11 corrected data: d10.H3.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
FMS VUE PUMP
Type of Device
DISTENSION UNIT, FLUID, ARTHROSCOPIC
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL
chemin-blanc 38
le locle 02400
SZ  02400
MDR Report Key9251953
MDR Text Key208354270
Report Number1221934-2019-59307
Device Sequence Number1
Product Code HRX
UDI-Device Identifier10886705020591
UDI-Public10886705020591
Combination Product (y/n)N
PMA/PMN Number
K130169
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup,Followup
Report Date 10/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/29/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number284002
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/08/2019
Date Manufacturer Received11/13/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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