KATECHO,INC PADPRO:AD;RTRANS EL/LW,PRE-CON; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
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Model Number 2001M-PC |
Device Problem
Fire (1245)
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Patient Problem
Insufficient Information (4580)
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Event Date 03/05/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The reported device is not being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.
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Event Description
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The sales representative reported on behalf of the customer that the 2001m-pc, padpro:ad;rtrans el/lw,pre-con was used during a code situation in cvicu on the date of (b)(6) 2023, when it was reported, ¿ we had an issue over the weekend with some 2001m-pc defib pads catching fire.It was in the cvicu department - in the middle of code, the pad sparked, popped, and produced a small flame and then went out.Bio med is checking head box to issues as well.They don¿t have the affected pads.(b)(6) asked the nurse if chloraprep had been used.The nurse was able to confirm if that was the case or not.¿.Further assessment answers were requested of the reporter and a good faith effort was completed; however, the reporter has not responded to our attempts for information.There was no patient or user injury, prolonged hospitalization, or medical intervention.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
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Manufacturer Narrative
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The device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.The manufacturing documents from the device history record have had a review requested from the contract manufacturer but it has not yet been received.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 15 complaints, regarding 17 devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).Per the instructions for use, the user is advised the following: that misuse (including reuse) of multifunction electrodes, use of compromised or altered product, and/or failure to follow product instructions may result in patient burns, inadequate delivery of therapy, and/or loss of ecg trace quality.Do not use multifunction electrodes in the presence of flammable agents or in an oxygen enriched atmosphere as this presents an explosion and fire hazard.We will continue to monitor for trends through the complaint system to assure patient safety.
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Event Description
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The sales representative reported on behalf of the customer that the 2001m-pc, padpro:ad;rtrans el/lw,pre-con was used during a code situation in cvicu on the date of (b)(6) 2023, when it was reported, ¿ we had an issue over the weekend with some 2001m-pc defib pads catching fire.It was in the cvicu department - in the middle of code, the pad sparked, popped, and produced a small flame and then went out.Bio med is checking head box to issues as well.They don¿t have the affected pads.(reporter) asked the nurse if chloraprep had been used.The nurse was able to confirm if that was the case or not.¿.Further assessment answers were requested of the reporter and a good faith effort was completed; however, the reporter has not responded to our attempts for information.There was no patient or user injury, prolonged hospitalization, or medical intervention.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
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