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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONTRACT MEDICAL INTERNATIONAL CLEARSIGHT FINGER CUFF SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

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CONTRACT MEDICAL INTERNATIONAL CLEARSIGHT FINGER CUFF SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE Back to Search Results
Model Number CSCM
Device Problems False Reading From Device Non-Compliance (1228); Incorrect, Inadequate or Imprecise Resultor Readings (1535); Pressure Problem (3012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/14/2016
Event Type  malfunction  
Manufacturer Narrative
The lot number was not provided; therefore, a review of the manufacturing records could not be completed. The device evaluation is anticipated and a supplemental report will be forthcoming with the evaluation results.
 
Event Description
It was reported that inaccurate pressure value was shown on the monitor when the measurement started with the clearsight finger cuff. The systolic pressure was over 200mmhg, while the expected value was around 100 to 120mmhg. The shape of the pressure waveform shown on the monitor was observed to be smooth. The patient was not treated based on the inaccurate value. Finger cuff was replaced and the problem was solved. There was no patient injury reported.
 
Manufacturer Narrative
Received one medium clearsight finger cuff. No visible damage was noticed from the returned unit. Pressure cuff inflated without any leakage during leak test which was performed both before and after decontamination. Information such as serial number, lot number, size, manufacture date of the unit were available during eeprom verification. Electrical testing also showed that all elements such as shield, led, and photodiode of returned unit were ok. Customer report of "inaccurate pressure value" was not able to be confirmed.
 
Manufacturer Narrative
Engineering evaluation results: the complaint was not confirmed. During the product evaluation, it was not possible to replicate the alleged inaccurate pressure value failure mode. Additionally, the returned finger cuff was not damaged and passed all the electrical testing performed. The finger cuff manufacturer reviewed their manufacturing records and did not find a non-conformance related to the customer complaint. Also, the patient was not treated using the complaint finger cuff as it was replaced by another finger cuff at the hospital.
 
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Brand NameCLEARSIGHT FINGER CUFF
Type of DeviceSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
Manufacturer (Section D)
CONTRACT MEDICAL INTERNATIONAL
vazni 848
hradec kralove
500 0 3
EZ 500 03
Manufacturer (Section G)
CONTRACT MEDICAL INTERNATIONAL
vazni 848
hradec kralove 500 0 3
EZ 500 03
Manufacturer Contact
brian hurd-servin
1 edwards way
irvine, CA 92614
9492506423
MDR Report Key5545892
MDR Text Key42507499
Report Number2015691-2016-01084
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K140312
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/17/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/04/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCSCM
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/13/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/09/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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