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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NATUS MEDICAL INC. DBA EXCLE-TECH LTD (XLTEK) PROTEKTOR; STIMULATOR, ELECTRICAL, EVOKED RESPONSE
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NATUS MEDICAL INC. DBA EXCLE-TECH LTD (XLTEK) PROTEKTOR; STIMULATOR, ELECTRICAL, EVOKED RESPONSE Back to Search Results
Model Number PROTEKTOR
Device Problems Break (1069); Device-Device Incompatibility (2919)
Patient Problems Burn(s) (1757); No Known Impact Or Consequence To Patient (2692)
Event Date 07/19/2016
Event Type  malfunction  
Manufacturer Narrative
The protektor system involved in the incident have been returned recently and a preliminary investigation is on-going.Natus will submit a follow up report once the investigation has been concluded.Device evaluation started, not completed.
 
Event Description
Protektor acquisition db cable was reported to be broken for pin 2, and the customer was wondering if this could be related to the incident where the patient was burned (two burns on the right shoulder (each used as a ground for acquisition box) one on the left abdomen (recording emg)).Blistering and darkening of tissue around the needle side was observed, but they do not present serious injury.Customer reported that the sub-dermal needle electrode plugged into acquisition box of protektor system caused the burn.Electro-cautery was also in use.
 
Manufacturer Narrative
Upon receipt of the device, (b)(4) engineering team conducted the device evaluation.The dab cable was found broken and the unit was not able to communicate with the computer.It was confirmed that such issues with the device could not have caused the patient burn.Once repaired, the device functioned to specification.Further investigation involving stimulation pulse measurement found that probe h was damaged and failed to meet the acceptance criteria.The damage indicates that an external high voltage source such as an electrocautery machine (esu) was being used at the same time as the protektor system.This is consistent with the report from the end user that electrocautery was used for the patient.The user manual for protektor system indicates not to use the system with esu at the same time due to burn hazard - see below for the user manual statement.Therefore, the burning on the patient occurred as a result of user error.The general warnings section states: "connection of a patient to high-frequency surgical equipment (electrocautery) and to an electromyograph or evoked response equipment simultaneously may result in burns at the site of the electrical stimulator or biopotential input part electrodes and possible damage to the electrical stimulator or biological amplifiers." a reminder has been sent to the user to follow the instruction and specifically informed of this warning in the user manual.
 
Event Description
Protektor acquisition db cable was reported to be broken for pin 2, and the customer was wondering if this could be related to the incident where the patient was burned (two burns on the right shoulder (each used as a ground for acquisition box) one on the left abdomen (recording emg)).Blistering and darkening of tissue around the needle side was observed, but they do not present serious injury.Customer reported that the sub-dermal needle electrode plugged into acquisition box of protektor system caused the burn.Electro-cautery was also in use.
 
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Brand Name
PROTEKTOR
Type of Device
STIMULATOR, ELECTRICAL, EVOKED RESPONSE
Manufacturer (Section D)
NATUS MEDICAL INC. DBA EXCLE-TECH LTD (XLTEK)
2568 bristol circle
oakville, oakville ontario L6H 5 S1
CA  L6H 5S1
Manufacturer (Section G)
NATUS MEDICAL INCORPORATED DBA EXCEL-TECH (XLTEK)
2568 bristol circle
oakville, ontario L6H5S 1
CA   L6H5S1
Manufacturer Contact
sanjay mehta
2568 bristol circle
oakville, ontario L6H5S-1
CA   L6H5S1
2875055
MDR Report Key5902709
MDR Text Key54033930
Report Number9612330-2016-00008
Device Sequence Number1
Product Code GWF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040358
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Other
Remedial Action Repair
Type of Report Initial,Followup
Report Date 07/27/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/24/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberPROTEKTOR
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/18/2016
Is the Reporter a Health Professional? No
Date Manufacturer Received07/27/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/02/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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