MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-05-25 for VEST MODEL 105 NA manufactured by Hill-rom Services Private Limited.
[2643790]
Hill-rom has received a report alleging that a pt believed the best may have contributed to an injury to her aorta where it split into three layers; however, the pt did not know if her belief was correct or not and her doctor did not tell her that the vest had contributed to the injury. Subsequent investigation revealed that her aorta was originally operated on years prior in (b)(6) 2008, and follow up with the clinical manager who spoke with the pt's doctor revealed that the doctor felt it was possible that the best may have been a contributing factor. The information from the clinical manager reasonably suggests that the vest may have contributed to the aorta injury. No device malfunction was alleged nor discovered through subsequent analysis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008145987-2012-00001 |
| MDR Report Key | 2595793 |
| Report Source | 05 |
| Date Received | 2012-05-25 |
| Date of Report | 2012-05-03 |
| Date of Event | 2012-01-07 |
| Date Mfgr Received | 2012-05-03 |
| Device Manufacturer Date | 2011-11-23 |
| Date Added to Maude | 2012-06-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | BRICE RICKER |
| Manufacturer Street | 4349 CORPORATE DRIVE |
| Manufacturer City | CHARLESTON SC 29405 |
| Manufacturer Country | US |
| Manufacturer Postal | 29405 |
| Manufacturer Phone | 8437408440 |
| Manufacturer G1 | HILL-ROM SERVICES PRIVATE LIMITED |
| Manufacturer Street | 1 YISHUN AVENUE 7 |
| Manufacturer City | SINGAPORE 768923 |
| Manufacturer Country | SN |
| Manufacturer Postal Code | 768923 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VEST MODEL 105 |
| Generic Name | POWERED PERCUSSOR |
| Product Code | BYI |
| Date Received | 2012-05-25 |
| Returned To Mfg | 2012-04-10 |
| Model Number | 105 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HILL-ROM SERVICES PRIVATE LIMITED |
| Manufacturer Address | 1 YISHUN AVE 7 SINGAPORE 768923 SN 768923 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening | 2012-05-25 |