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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL 4176 FOOT PED BOARD 4WAY FOOT-SWITCH, ELECTRICAL

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MEDOS INTERNATIONAL SARL 4176 FOOT PED BOARD 4WAY FOOT-SWITCH, ELECTRICAL Back to Search Results
Model Number 284176
Device Problem Infusion or Flow Problem (2964)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Additional narrative: udi: (b)(4). Investigation summary: the device was received and evaluated at the service center. The reported complaint that the canula and suction function of the device did not work, was unable to be confirmed. No defects were found with the device upon evaluation. The device was however serviced and found to be functioning according to specifications. Since the reported condition is not confirmed, the root cause for the reported failure cannot be determined. No manufacturing record evaluation is required as no manufacturer or service related issues were found with the device. 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.
 
Event Description
It was reported by the customer in (b)(6) that the canula and suction function of a footswitch device did not work. There was no procedure nor patient involvement reported. No additional information was provided.
 
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Brand Name4176 FOOT PED BOARD 4WAY
Type of DeviceFOOT-SWITCH, ELECTRICAL
Manufacturer (Section D)
MEDOS INTERNATIONAL SARL
chemin blanc 38
le locle CH-24 00
SZ CH-2400
Manufacturer (Section G)
MEDOS INTERNATIONAL SARL
chemin blanc 38
le locle CH-24 00
SZ CH-2400
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6013142063
MDR Report Key11597531
MDR Text Key243499969
Report Number1221934-2021-01060
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodePO
PMA/PMN Number
K954465
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/31/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number284176
Device Catalogue Number284176
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/26/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/19/2021
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 Initial

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