MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2013-04-05 for VEST MODEL 105 8105 P105CM manufactured by Hill-rom Services Private Ltd.
[3393740]
Hill-rom received a complaint on one of its vest model 105 airway clearance devices alleging the patient's rib was fractured after treatment. The report indicated that the patient had used the device slightly longer than what was recommended by her trainer. No malfunction of the device was alleged nor found through the analysis of the unit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045510-2013-00009 |
| MDR Report Key | 3054831 |
| Report Source | 99 |
| Date Received | 2013-04-05 |
| Date of Report | 2013-03-27 |
| Date of Event | 2013-03-27 |
| Date Facility Aware | 2013-03-27 |
| Report Date | 2013-04-05 |
| Date Reported to FDA | 2013-04-05 |
| Date Added to Maude | 2013-04-15 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Street | 4349 CORPORATE RD. |
| Manufacturer City | CHARLESTON SC 29405 |
| Manufacturer Country | US |
| Manufacturer Postal | 29405 |
| Manufacturer G1 | HILL-ROM MANUFACTURING, INC. |
| Manufacturer Street | 4349 CORPORATE RD. |
| Manufacturer City | CHARLESTON SC 29405 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 29405 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VEST MODEL 105 |
| Generic Name | PERCUSSOR, POWERED-ELECTRIC |
| Product Code | BYE |
| Date Received | 2013-04-05 |
| Returned To Mfg | 2013-03-27 |
| Model Number | 8105 |
| Catalog Number | P105CM |
| Device Expiration Date | 2012-12-19 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | 1 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HILL-ROM SERVICES PRIVATE LTD |
| Manufacturer Address | 1 YISHUN AVE 7 SINGAPORE 768923 SN 768923 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-04-05 |