Model Number K063 |
Device Problem
Defective Device (2588)
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Patient Problems
Cardiac Arrest (1762); Pneumothorax (2012); Asystole (4442); Respiratory Insufficiency (4462)
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Event Date 08/20/2021 |
Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that the patient needed his pacemaker to be replaced and he needed a magnetic resonance imaging (mri) scan.It was reported that the patient's heart had stopped for 10 minutes, his lungs had collapsed, and he had to have a tube put in.Afterwards, the patient spent a month in rehab.The pacemaker remains implanted.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Removed 9227/pneumothorax and 102/intubation; updated to 9242/respiratory distress.Removed f1205/temporary impairment as f1203 covers the severity of the life threatening event.F2203 was also removed as the needed mri was not related to this event.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that the patient needed his pacemaker to be replaced and he needed a magnetic resonance imaging (mri) scan.It was reported that the patient's heart had stopped for 10 minutes, his lungs had collapsed, and he had to have a tube put in.Afterwards, the patient spent a month in rehab.The pacemaker remains implanted.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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