MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2013-07-11 for VEST SYSTEM MODEL 105 8105 P105CM manufactured by Hill-rom Services Private Limited.
[3576012]
Hill-rom received a complaint with one of its vest model 105 airway clearance systems where the pt alleged back pain after use. The pt had an x-ray of which revealed a slight fracture of a vertebra in his back. There were no alleged malfunctions of the device and it was inspected by the importer and it was found to be operating within specifications. Hill-rom is conservatively reporting this adverse event due to an alleged serious injury and no malfunction of the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008145987-2013-00002 |
| MDR Report Key | 3231914 |
| Report Source | 00 |
| Date Received | 2013-07-11 |
| Date of Report | 2013-06-12 |
| Date of Event | 2013-06-12 |
| Date Facility Aware | 2013-06-12 |
| Report Date | 2013-06-12 |
| Date Mfgr Received | 2013-06-12 |
| Device Manufacturer Date | 2013-04-19 |
| Date Added to Maude | 2013-07-18 |
| 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 | ROBERT FARLEY |
| Manufacturer Street | 4349 CORPORATE ROAD |
| Manufacturer City | CHARLESTON SC 29405 |
| Manufacturer Country | US |
| Manufacturer Postal | 29405 |
| Manufacturer Phone | 8437408506 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VEST SYSTEM MODEL 105 |
| Generic Name | PERCUSSOR, POWERED-ELECTRIC |
| Product Code | BYI |
| Date Received | 2013-07-11 |
| Returned To Mfg | 2013-07-02 |
| Model Number | 8105 |
| Catalog Number | P105CM |
| Device Expiration Date | 2013-04-19 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| 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 AVENUE 7 SINGAPORE 768923 SN 768923 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-07-11 |