MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2012-11-01 for VEST MODEL 105 NA manufactured by Hillrom Services Private Limited.
[3057613]
Hill-rom received and report that reasonably suggested that the vest may have contributed to a collapsed lung. The unit was evaluated and no problem was found.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008145987-2012-00004 |
| MDR Report Key | 2895346 |
| Report Source | 04 |
| Date Received | 2012-11-01 |
| Date of Report | 2012-10-09 |
| Date of Event | 2012-09-28 |
| Date Mfgr Received | 2012-10-09 |
| Device Manufacturer Date | 2012-09-18 |
| Date Added to Maude | 2013-01-04 |
| 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 Street | 4349 CORPORATE DR |
| Manufacturer City | CHARLESTON SC 29405 |
| Manufacturer Country | US |
| Manufacturer Postal | 29405 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VEST MODEL 105 |
| Generic Name | POWERED PERCUSSOR |
| Product Code | BYI |
| Date Received | 2012-11-01 |
| Returned To Mfg | 2012-10-26 |
| 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 | HILLROM SERVICES PRIVATE LIMITED |
| Manufacturer Address | 1 YISHUN AVENUE 7 SINGAPORE 768923 SN 768923 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2012-11-01 |