MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2012-10-11 for VEST MODEL 105 NA manufactured by Hillrom Services Private Limited.
[3023308]
Hill-rom has received a report alleging that the patient's ribs were fractured. The report indicates that the fractured ribs were identified after use of the vest. No malfunction of the unit was alleged or found through evaluation of the unit.
Patient Sequence No: 1, Text Type: D, B5
[10266810]
No malfunction of the device was alleged or found through evaluation of the unit.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008145987-2012-00003 |
| MDR Report Key | 2821315 |
| Report Source | 04 |
| Date Received | 2012-10-11 |
| Date of Report | 2012-09-21 |
| Date of Event | 2012-08-22 |
| Date Mfgr Received | 2012-09-21 |
| Device Manufacturer Date | 2012-07-20 |
| Date Added to Maude | 2012-11-07 |
| 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 |
| Single Use | 3 |
| Remedial Action | RP |
| 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 | 2012-10-11 |
| Returned To Mfg | 2012-10-02 |
| 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. Required No Informationntervention | 2012-10-11 |