MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-02-22 for VEST MODEL P105A manufactured by Hill-rom Singapore.
[38664472]
The account did not allege any malfunction of the vest unit. Patient's fractures are most likely related to her underlying pathology and not the use of the vest. There was no evidence of a malfunction and the device performed as intended. Bronchiectasis w (acute) exac copd nos patient reports history of osteoporosis.
Patient Sequence No: 1, Text Type: N, H10
[38664473]
Hill-rom received a report from the account stating the patient was complaining about discomfort in her back. The patient stated the pain increased and she went to the emergency room. The patient was diagnosed with a fractured l2 vertebrae. The unit was located in the patients home. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008145987-2016-00001 |
| MDR Report Key | 5450829 |
| Report Source | CONSUMER |
| Date Received | 2016-02-22 |
| Date of Report | 2016-02-03 |
| Date of Event | 2016-01-31 |
| Date Mfgr Received | 2016-02-03 |
| Date Added to Maude | 2016-02-22 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | TONY WERNER |
| Manufacturer Street | 1069 STATE ROUTE 46 EAST |
| Manufacturer City | BATESVILLE IN 47006 |
| Manufacturer Country | US |
| Manufacturer Postal | 47006 |
| Manufacturer Phone | 8129312359 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VEST MODEL P105A |
| Generic Name | THE VEST |
| Product Code | BYI |
| Date Received | 2016-02-22 |
| Model Number | P105A |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HILL-ROM SINGAPORE |
| Manufacturer Address | 1 YISHUN AVENUE 7 SINGAPORE, NORTH EAST 768923 SN 768923 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-02-22 |