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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) COMPUTER, DIAGNOSTIC, PROGRAMMABLE

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BIOSENSE WEBSTER, INC. (JUAREZ) COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Model Number D-1286-03-S
Device Problems Leak/Splash (1354); Failure to Transmit Record (1521); Device Displays Incorrect Message (2591); Material Twisted/Bent (2981); Noise, Audible (3273)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/16/2017
Event Type  malfunction  
Manufacturer Narrative
The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed. Since no lot number was provided, no device history record (dhr) review could be performed. Manufacturer's ref. No: (b)(4).
 
Event Description
It was reported that a patient underwent an ablation procedure with a c3 interface cable ¿ therapeutic and a noise issue occurred. The patient was not under general anesthesia. When the ablation catheter was plugged into the patient interface unit, a current leakage error and a force data streaming error occurred. There was an electrocardiogram (ecg) signal noise and signal loss when these errors occurred. The ecg noise/signal loss was on body surface and intracardiac signals as well as on the carto and recording system. There was no ecg signal available for the physician to monitor the patient¿s heart rhythm. The catheter was unplugged and the resterilized cable was changed. It was also noted that initial cable had twisted pins. The current leakage error was then resolved, but the force error remained. The catheter was changed and the force error cleared. The procedure was completed with no patient consequence. The force error is not mdr reportable because the risk to the patient is low. However, the inability to monitor the patient¿s ecg rhythm while devices are intra cardiac might lead to an undetected cardiac rhythm that could be life threatening.
 
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Type of DeviceCOMPUTER, DIAGNOSTIC, PROGRAMMABLE
Manufacturer (Section D)
BIOSENSE WEBSTER, INC. (JUAREZ)
circuito interior norte #1820
parque industrial salvacar
juarez, chihuahua 32599
MX 32599
Manufacturer (Section G)
BIOSENSE WEBSTER, INC. (JUAREZ)
circuito interior norte #1820
parque industrial salvacar
juarez, chihuahua 32599
MX 32599
Manufacturer Contact
joaquin kurz
33 technology drive
irvine, CA 92618
9497893837
MDR Report Key6306225
MDR Text Key66927193
Report Number9673241-2017-00094
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K090017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 01/16/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/06/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberD-1286-03-S
Device Catalogue NumberCR3434CT
Device Lot NumberUNKNOWN_D-1286-03-S
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/16/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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