Model Number M-5463-01 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
Burn(s) (1757)
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Event Date 10/21/2013 |
Event Type
Injury
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Event Description
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On (b)(4) 2014, bwi received information from the account regarding this event.Per the information provided by the account, the patient underwent a cardiac ablation procedure on (b)(6) 2013.Following the procedure, the patient was noted to have sustained a well demarcated burn to her right flank with blisters from the grounding pad.Wound care was ordered both during hospitalization and after discharge per the wound clinic.No prior notice of the alleged event was reported until (b)(6) 2014.During additional investigation with the bwi representative, it was found that in (b)(6) 2014, the bwi representative was informed about this event which resulted in skin burn with a scar.Based on the information received, the degree of the skin burn remains unknown; however, third degree skin burn cannot be ruled out making this event reportable.
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Manufacturer Narrative
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The hardware investigation has begun but it has not been completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Concomitant product used: product name: sf fj nav thermcool; us catalog #: unknown; lot #: unknown.Non-bwi product used: product name: stryker cs bidirectional decapolar df catheter, catalog #: unknown.(b)(4).
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Manufacturer Narrative
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(b)(4).On (b)(6) 2014, bwi received information from the account regarding this event.Per the information provided by the account, the patient underwent a cardiac ablation procedure on (b)(6) 2013.Following the procedure, the patient was noted to have sustained a well demarcated burn to her right flank with blisters from the grounding pad.Wound care was ordered both during hospitalization and after discharge per the wound clinic.No prior notice of the alleged event was reported until (b)(6) 2014.During additional investigation with the bwi representative, it was found that in (b)(6) 2014, the bwi representative was informed about this event which resulted in skin burn with a scar.Based on the information received, the degree of the skin burn remains unknown however third degree skin burn cannot be ruled out making this event reportable.The investigational analysis has been completed.It was confirmed that it was non bwi related issue.Device is working fine.No malfunction of device reported.Customer does not want the system checked.The device history record was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.
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Search Alerts/Recalls
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