Description of Event or Problem · 1
(B)(6) HAS BEEN RETAINED BY THE (B)(6) FAMILY TO INVESTIGATE THE DEATH OF THEIR SON, (B)(6). (B)(6) WAS COMPLETELY DEPENDENT ON THE PULMONETIC LTV950 VENTILATOR MANUFACTURED BY CAREFUSION. THE VENTILATOR WAS SUPPLIED BY (B)(4), BUT WAS OWNED BY (B)(4). (B)(6) WAS HOSPITALIZED AFTER AN LTV950 MALFUNCTIONED IN (B)(6) AND (B)(6) 2009. AN LTV950 HE WAS USING, MALFUNCTIONED AGAIN ON (B)(6) 2010. (B)(6) DIED FOLLOWING THE (B)(6) 2010 MALFUNCTION OF THE LTV950. (B)(4). PURSUANT TO THE FDA MEDICAL DEVICE REPORTING ("MDR") REGULATION (21 CFR 803 ET. SEQ.), A MANUFACTURER AND/OR DISTRIBUTOR HAS THE AFFIRMATIVE DUTY TO REPORT DEVICE MALFUNCTIONS, SERIOUS INJURIES, OR DEATHS ASSOCIATED WITH MEDICAL DEVICES TO THE FDA AFTER BECOMING AWARE OF THE EVENT(S). PURSUANT TO THE FREEDOM OF INFO ACT ("FOIA") (B)(6) SEEKS INFO REGARDING WHETHER CAREFUSION, (B)(4) HAS COMPLIED WITH THE MDR REGULATION AS IT RELATES TO (B)(6) VENTILATOR(S). PARTICULARLY, WE INQUIRE WHETHER CAREFUSION REPORTED TO THE FDA THAT THE PULMONETIC LTV950 MALFUNCTIONED IN (B)(6) AND (B)(6) 2009 AND (B)(6) 2010, AND WHETHER CAREFUSION, (B)(4) REPORTED (B)(6) DEATH BEFORE OR AFTER (B)(6) 2010. IN ADDITION, WE WOULD LIKE ANY INFO REGARDING WHETHER AN INVESTIGATION HAS BEEN CONDUCTED RELATING TO (B)(6) VENTILATOR(S) AND/OR THE PULMONETIC LTV950 SERIES, THE RESULTS AND CONCLUSIONS DRAWN FROM THE INVESTIGATION(S), WHETHER THE PULMONETIC LTV950 HAS BEEN THE SUBJECT OF OTHER MDR DISCLOSURES, AND ANY OTHER REVIEWS, DOCUMENTS, OR REPORTS RELATING TO (B)(6) VENTILATOR(S) AND THE PULMONETIC LTV950.