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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT CONTROLLER ONLY CONTROLLER, INFUSION, INTRAVASCULAR, ELECTRONIC

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CONSOLIDATED MEDICAL EQUIPMENT CONTROLLER ONLY CONTROLLER, INFUSION, INTRAVASCULAR, ELECTRONIC Back to Search Results
Catalog Number S2
Device Problem Restricted Flow rate (1248)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The reported device is being returned to conmed for evaluation. A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation. This issue will continue to be monitored through the complaint system to assure patient safety.
 
Event Description
This distributor reported on behalf of their customer that the s2 device had a low flow rate during pre-op testing. It was not determined if the pre-op testing occurred inside or outside the sterile field. There was no report of injury to user or any type of patient involvement. Further assessment information was requested; however, to date, no further information has been obtained. This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
 
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Brand NameCONTROLLER ONLY
Type of DeviceCONTROLLER, INFUSION, INTRAVASCULAR, ELECTRONIC
Manufacturer (Section D)
CONSOLIDATED MEDICAL EQUIPMENT
alejandro dumas ave, 11321
complejo industrial chihuahua
chihuahua, 31136
MX 31136
Manufacturer (Section G)
CONSOLIDATED MEDICAL EQUIPMENT
alejandro dumas ave, 11321
complejo industrial chihuahua
chihuahua, 31136
MX 31136
Manufacturer Contact
john berga
11311 concept blvd.
largo, FL 33773
7273995358
MDR Report Key8528394
MDR Text Key145371613
Report Number3007305485-2019-00134
Device Sequence Number1
Product Code LDR
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K905498/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/14/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberS2
Device Lot Number201710205
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/10/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/13/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/20/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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