Model Number MSERIES BI-PHASIC |
Device Problems
Device Operates Differently Than Expected (2913); Device Sensing Problem (2917)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Type
malfunction
|
Manufacturer Narrative
|
Zoll medical corporation has received the product and will be providing a follow-up report when our investigation is completed.
|
|
Event Description
|
Complainant indicated that while attempting to treat a patient (age & gender unknown) the device was unable to obtain an ecg signal via electrode pads.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
|
|
Manufacturer Narrative
|
The device was returned to zoll medical corporation; the malfunction was observed and attributed to a loose component on the system board.The cause was determined to be related to oxidation of the plating on this 10 year old board.The system board was replaced to resolve the malfunction.Analysis for reports of this type has not identified an increase in trend.
|
|
Search Alerts/Recalls
|