FDA Adverse Event Injury Summary report: N

VEST

MDR report key: 661569 · Received January 4, 2006

Report

Report Number
1045510-2006-00001
Event Type
Injury
Date Received
January 4, 2006
Report Date
December 5, 2005
Manufacturer
HILL-ROM CHARLESTON
Product Code
BYI
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
AR, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

MALE SUFFERED AN ANOXIC EPISODE AT 6 WEEKS OF AGE RESULTING IN CEREBRAL PALSY, SEIZURES AND SEVERE DEVELOPMENTAL DELAY. HIS FIRST PULMONARY VISIT OCCURRED AT 11 YEARS FOR A SURGICAL EVALUATION FOR SCOLIOSIS REPAIR. AT THAT TIME HE DEMONSTRATED A HYPOPNEIC BREATHING PATTERN WITH A RESTING TIDAL VOLUME OF ONLY 3.6 ML/KG. HE WAS ALSO NOTED TO HAVE AN INEFFECTIVE COUGH WITH INABILITY TO CLEAR SECRETIONS. HE WAS PRESCRIBED A VEST AND MECHANICAL INSUFFLATOR-EXSUFFLATOR (MI-E). THE MI-E WAS DENIED BY INSURANCE SO ONLY THE VEST WAS BEGUN. TWO MONTHS LATER HE WAS ADMITTED TO THE PICU FOR ASPIRATION VERSUS MUCUS PLUGGING. THE FAMILY MEMBER REPORTED AN EVENT WHICH OCCURRED DURING VEST THERAPY IN WHICH LARGE AMOUNTS OF SECRETIONS WERE PRODUCED FOLLOWED BY DESATURATION AND RESPIRATORY DISTRESS. FOLLOWING A 2.5 MONTH HOSP STAY, HE WAS DISCHARGED WITH NOTURNAL NON-INVASIVE MECHANICAL VENTILATION AND A MI-E. HE CONTINUES TO RECEIVE VEST TREATMENTS, HOWEVER NOW FOLLOWED BY MI-E.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 VEST POWERED PERCUSSOR BYI HILL-ROM CHARLESTON 104 NA

Patients

Seq Age Sex Outcome Treatment
1 11 YR Hospitalization