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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US REMOTE CONTROL(FMS VUE/NEXTRA) FOOT-SWITCH, ELECTRICAL

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DEPUY MITEK LLC US REMOTE CONTROL(FMS VUE/NEXTRA) FOOT-SWITCH, ELECTRICAL Back to Search Results
Model Number 283551
Device Problem Intermittent Continuity (1121)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/19/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Investigation summary: according to the information provided, it was reported by the healthcare professional via email that the remote control is not working. The customer did not have additional information to provide. The complaint device was received and evaluated. Visual observations reveals the device is slightly worn, the control is observed in a different color, which makes it look old. It was functionally tested with a pump several times and it revealed that the buttons for run and stop were not functioning as expected, they were jammed, including the parameters: pressure, suction, and speed. Because of this, the control was recognized, but the pump was activated with an intermittent operation. This complaint can be confirmed. The possible root cause could be an internal wear of electrical components in the buttons; as well as rough use by the user. However, this cannot be conclusively affirmed. As a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required.  at this point in time, no corrective action is required, and no further action is warranted. However, depuy synthes 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. Udi:(b)(4).
 
Event Description
It was reported by the healthcare professional via email that the remote control is not working. The device is available to be returned for evaluation. The customer did not have additional information to provide.
 
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Brand NameREMOTE CONTROL(FMS VUE/NEXTRA)
Type of DeviceFOOT-SWITCH, ELECTRICAL
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
DEPUY MITEK
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key10693572
MDR Text Key212575103
Report Number1221934-2020-03046
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K041824
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation
Type of Report Initial
Report Date 10/04/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number283551
Device Catalogue Number283551
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/25/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/04/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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