Model Number CARDIOHELP |
Device Problem
Display or Visual Feedback Problem (1184)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/14/2020 |
Event Type
malfunction
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Manufacturer Narrative
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A follow up will be submitted when additional information becomes available.
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Event Description
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It was reported that the touch panel was not responding during patient treatment.No indication of actual, potential for harm, or death.Complaint number: (b)(4).
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Event Description
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Complaint number: (b)(4).
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Manufacturer Narrative
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It was reported that the touch panel was not responding during patient treatment.No indication of actual or potential for harm or death.According to the service order report (b)(4) (dated 2021-01-25/26) the getinge service technician replaced the ch user interface hardware update kit (701073922).After replacement the unit passed all tests and was cleared for clinical use.Thus the failure could be confirmed.The root causes for the reported failures to the cardiohelp touch panel is not responding is a known failure.The touch panel foil (material#70505.3579_rev.02) which was used formerly showed an increased rate of connection problems.As a solution for that a new touch panel was implemented as part of the cardiohelp user interface hardware update kit (material#70107.3922) in september, 2019.Regarding to the replacement of this part a service bulletin (issue 82 / 2019-09-25) was already provided.The occurrence rate was calculated for the reported issue and it was determined that this is not a systemic issue.Therefore, no remedial action is required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.Note: the in the service order report (b)(4) mentioned defective venous bubble sensor will be investigated in the complaint#(b)(4).
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Search Alerts/Recalls
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