MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2015-09-04 for CONTROLLER, VEST 105 P105CM manufactured by Hill-rom Singapore.
[25050755]
The patient stated that he was using the vest for about 2 weeks. He stated that he has had bronchiectasis and hemorrhaging previously. The patient stated he was admitted for 8 days due to a pulmonary hemorrhage. The patient received testing, therapy breathing treatments, antibiotics and had a bronchoscopy that was clear. Patient's pulmonary hemorrhage is most likely related to his underlying pathology. The use of the vest could have contributed to the incident. This is not indicative of a malfunction. The patient did not allege any malfunction of the vest unit. The vest unit is being returned but has not yet been evaluated.
Patient Sequence No: 1, Text Type: N, H10
[25050756]
Hill-rom received a report from the patient stating he developed a pulmonary hemorrhage. The unit was located at the patients home. This report was filed in our complaint handling system as (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008145987-2015-00001 |
| MDR Report Key | 5057527 |
| Report Source | CONSUMER |
| Date Received | 2015-09-04 |
| Date of Report | 2015-08-06 |
| Date of Event | 2015-06-01 |
| Date Mfgr Received | 2015-08-06 |
| Date Added to Maude | 2015-09-04 |
| 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 | CONTROLLER, VEST 105 |
| Generic Name | THE VEST |
| Product Code | BYI |
| Date Received | 2015-09-04 |
| Model Number | P105CM |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2015-09-04 |