Model Number LUCAS |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bruise/Contusion (1754); Hemorrhage/Bleeding (1888); Laceration(s) (1946)
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Event Date 04/06/2021 |
Event Type
Death
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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.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 issue 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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A customer contacted physio-control to report that some injuries associated with resuscitation were noted at post-mortem of the patient.It was observed that the patient had chest hemorrhage with ascending aorta adventitial dissection with cardiac tamponade, pericardial tearing with myocardial hemorrhage and bruising.The patient associated with the reported event did not survive.
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Manufacturer Narrative
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The customer was contacted numerous times for more details, but no response appears to be forthcoming.The device has not been returned to physio-control for evaluation for this reported issue.The reported issue could not be verified and the cause of the reported issue could not be determined.The device was evaluated in august 2021 and the device passed all functional and performance testing.
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Event Description
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A customer contacted physio-control to report that some injuries associated with resuscitation were noted at post-mortem of the patient.It was observed that the patient had chest hemorrhage with ascending aorta adventitial dissection with cardiac tamponade, pericardial tearing with myocardial hemorrhage and bruising.The patient associated with the reported event did not survive.
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Manufacturer Narrative
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Section d4, serial no of the initial medwatch report indicates (b)(6).Section d4, serial no of the initial medwatch report should indicate (b)(6).Section h4, manufacturing date of the initial medwatch report indicates 11/13/2019.Section h4, manufacturing date of the initial medwatch report should be 10/31/2019.
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Event Description
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A customer contacted physio-control to report that some injuries associated with resuscitation were noted at post-mortem of the patient.It was observed that the patient had chest hemorrhage with ascending aorta adventitial dissection with cardiac tamponade, pericardial tearing with myocardial hemorrhage and bruising.The patient associated with the reported event did not survive.
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Manufacturer Narrative
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The sales representative informed that the serial number was reported in error and that it is unknown.Section d4, serial no of the initial medwatch report indicates (b)(6).Section d4, serial no of the initial medwatch report should indicate unknown.Section h4, manufacturing date of the initial medwatch report indicates 10/31/2019.Section h4, manufacturing date of the initial medwatch report should be blank.
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Event Description
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A customer contacted physio-control to report that some injuries associated with resuscitation were noted at post-mortem of the patient.It was observed that the patient had chest hemorrhage with ascending aorta adventitial dissection with cardiac tamponade, pericardial tearing with myocardial hemorrhage and bruising.The patient associated with the reported event did not survive.
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Manufacturer Narrative
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Section h10 and/or 11, additional mfg narrative of the supplemental medwatch report (002) indicates the customer was contacted numerous times for more details, but no response appears to be forthcoming.The device has not been returned to physio-control for evaluation for this reported issue.The reported issue could not be verified and the cause of the reported issue could not be determined.The device was evaluated in august 2021 and the device passed all functional and performance testing.Section h10 and/or 11, additional mfg narrative of the supplemental medwatch report (002) should indicate a stryker clinical specialist performed a clinical review and it was determined that due to lack of information it can not be excluded or confirmed that the reported injuries could have been caused by cpr, manual or mechanical.The customer was contacted numerous times for more details, but no response appears to be forthcoming.The device has not been returned to physio-control for evaluation for this reported issue.The reported issue could not be verified and the cause of the reported issue could not be determined.
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Event Description
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A customer contacted physio-control to report that some injuries associated with resuscitation were noted at post-mortem of the patient.It was observed that the patient had chest hemorrhage with ascending aorta adventitial dissection with cardiac tamponade, pericardial tearing with myocardial hemorrhage and bruising.The patient associated with the reported event did not survive.
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Search Alerts/Recalls
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