| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | VEST MODEL | THE VEST | HILLROM SINGAPORE | BYI | P105A | Y | Y |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2014-02-14 | 0 | 1. R |
Patient 1
HILL-ROM RECEIVED A REPORT FROM A PATIENT STATING THAT HER RIGHT LUNG COLLAPSED AFTER USING THE VEST. THE REPORT FROM THE PATIENT INDICATES SHE WAS TRAINED ON A WRAP GARMENT AND GIVEN THE PRESCRIBED SETTING. THE GARMENT WAS CHANGED OUT BY HER HCT, TO A FULL GARMENT BUT THEY DID NOT PROVIDE HER THE SETTINGS TOO USE, SO SHE USED THE SETTINGS FOR THE WRAP. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).
Patient 1
DEVELOPMENT OF SECONDARY SPONTANEOUS PNEUMOTHORACES (SSPS), BY DEFINITION, OCCURS IN INDIVIDUALS WITH SIGNIFICANT UNDERLYING LUNG DISEASE AND CANNOT ONLY BE ATTRIBUTED TO PERFORMANCE OF THE VEST. THE MOST COMMON UNDERLYING LUNG DISEASE IS CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)., WHICH ACCOUNTS FOR APPROXIMATELY 70% OF CASES. THIS PATIENT IN PARTICULAR HAD A NUMBER OF CHRONIC PULMONARY CONDITIONS INCLUDING ASTHMA, CONCHITIS, COPD, PNEUMONIA, AND MYCOBACTERIUM AVIUM INTRACELLULARE. INVESTIGATION INDICATED THAT THERE WAS NO EVIDENCE OF A DEVICE MALFUNCTION OR A FAILURE TO MEET SPECIFICATION. THE UNIT WAS BROUGHT BACK AND INSPECTED AND NO PROBLEMS WERE FOUND. THE PATIENT STATED SHE HAD A PROCEDURE TO "REGLUE" HER LUNG. IMAGING STUDIES PERFORMED ON (B)(6) 2013, SHOW NO PNEUMOTHORAX AS IT HAD RESOLVED.