Model Number LUCAS |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Multiple Fractures (4519)
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Event Date 06/01/2021 |
Event Type
Injury
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Manufacturer Narrative
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Physio-control contacted the customer to request additional information on the patient.No response has been received from the customer.Patient fields in which information is not provided were intentionally left blank.Physio-control will not request any patient identifying information to be in accordance with regulation (eu) 2016/679 of the european parliament and of the council.Physio-control continues to investigate the reported failure and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.
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Event Description
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Physio-control was made aware of the article in kristianstadsbladet, published on 6/22/2021.The article is describing the observations made by the pathologist team regarding the usage of the device on patients.It was observed that the device would potentially cause damage to bones and organs, and cause a greater number of fractures.During autopsies of patients who have died, it was observed that those who received cardiopulmonary resuscitation (cpr) with the device had significantly greater injuries in comparison to manual cpr.
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Event Description
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Physio-control was made aware of the article in kristianstadsbladet, published on 6/22/2021.The article is describing the observations made by the pathologist team regarding the usage of the device on patients.It was observed that the device would potentially cause damage to bones and organs, and cause a greater number of fractures.During autopsies of patients who have died, it was observed that those who received cardiopulmonary resuscitation (cpr) with the device had significantly greater injuries in comparison to manual cpr.
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Manufacturer Narrative
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The article from a newspaper, not a scientific journal, are observational comments from the customer and not about a special patient case, therefore it is difficult to make a clinical review from the information received in the article.However, the lucas device has been shown in randomised clinical trial to have the same injury pattern as manual cpr.The customer was contacted multiple times however no serial number was provided and the device was not returned for evaluation.No device malfunction or specific instances of injuries were alleged, only general observation of injuries over time.The root cause of the reported issue could not be determined.
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Search Alerts/Recalls
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