MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2013-12-05 for VEST MODEL 105 8105 P105CM manufactured by Hill-rom Services Private Limited.
[4108410]
Hill-rom received a complaint on a vest model 105 airway clearance device alleging a patient had suffered from pain in his back and sides during treatments. On the third day of treatment, he alleged severe back pain requiring assistant to get out of bed. The patient also alleged severe bruising to his left arm which he could be determine the cause. The complaint report indicates the patient went to an emergency room after contacting his doctor where a mri was taken and identified two old and one new compression fractures to his spinal cord. He was treated with steroid injections to relieve alleged back pain but no information was provided regarding treatment of the alleged contusion suffered to his left arm. There were no reports of a device malfunction and it was returned to importer site where it was inspected and determined to operate within its specifications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008145987-2013-00003 |
| MDR Report Key | 3521282 |
| Report Source | 00 |
| Date Received | 2013-12-05 |
| Date of Report | 2013-11-06 |
| Date of Event | 2013-11-06 |
| Date Facility Aware | 2013-11-06 |
| Report Date | 2013-11-06 |
| Date Mfgr Received | 2013-11-06 |
| Device Manufacturer Date | 2013-08-19 |
| Date Added to Maude | 2013-12-17 |
| 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 MODEL 105 |
| Generic Name | PERCUSSOR, POWERED-ELECTRIC |
| Product Code | BYI |
| Date Received | 2013-12-05 |
| Returned To Mfg | 2013-11-20 |
| Model Number | 8105 |
| Catalog Number | P105CM |
| Lot Number | NA |
| Device Expiration Date | 2013-08-19 |
| 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 AVENUE 7 SINGAPORE 768923 SN 768923 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-12-05 |