D
Patient 1
HILL-ROM RECEIVED A REPORT FORM A PATIENT STATING HE WAS EXPERIENCING CHEST PAIN AND SHORTNESS OF BREATH. THE VEST WAS LOCATED IN THEIR HOME. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).
MAUDE MDR 3800232
- MDR report key
- 3800232
- Report number
- 3008145987-2014-00002
- Event key
- 0
- Event type
- 3
- Date of event
- 2014-03-19
- Date received
- 2014-04-30
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- JOHN CUMMINGS
- Address
- 1069 STATE ROUTE 46 EAST BATESVILLE IN 47006 US
- Phone
- 812-812-8129
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | VEST MODEL | THE VEST | BYI | P105C | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2014-04-30 | 0 | 1. H |
Event Narratives#
N
Patient 1
I CALLED (B)(6) THE PATIENT, TO DISCUSS THE ALLEGATION OF A CHEST PAIN AND SHORTNESS OF BREATH. (B)(6) BELIEVES THE VEST WAS WORKING PROPERLY AND THAT HE SHOULD HAVE PROBABLY NOT BEEN WEARING THE VEST WITH HIS MEDICAL CONDITION. (B)(6) STATED HE WENT INTO THE HOSPITAL FOR A BRONCHOSCOPY ON FRIDAY (B)(6) 2014. HE RETURNED HOME AND WAS READMITTED TO THE EMERGENCY ROOM SATURDAY (B)(6) 2014. HE HAD NOT BEEN WEARING THE VEST AT ANY POINT. HIS TEST CAME BACK NEGATIVE ON SATURDAY AND WAS RELEASED. HE STATED HE FELT BETTER ON TUESDAY (B)(6) 2014, HE USED THE VEST THAT EVENING AND INTO WEDNESDAY MORNING. LATER THAT DAY HIS SYMPTOMS OF CHEST PAIN AND SHORTNESS OF BREATH RETURNED. PATIENT WAS OUT OF TOWN BUT WENT DIRECTLY TO THE EMERGENCY ROOM AFTER RETURNING HOME THURSDAY (B)(6) 2014. AT THIS POINT HE WAS DIAGNOSED WITH A PLEURAL EFFUSION AND WAS ADMITTED TO THE HOSPITAL FOR SIX DAYS AND HAD CHEST TUBES DUE TO HIS PRIOR CONDITION AND DID NOT BELIEVE THE VEST WAS CAUSING THE INJURY. SINCE BEING RELEASED FROM THE HOSPITAL HE HAS NOT WORN THE VEST DUE TO THE SUTURES ON HIS SIDE. THE VEST WAS SENT BACK TO HILL-ROM FOR INVESTIGATION AND THE ENGINEERING INVESTIGATION CONCLUDED THAT THE VEST PASSED ALL PERFORMANCE TESTING AND DID FUNCTION AS DESIGN. THERE IS NO CLEAR CAUSAL RELATION BETWEEN THE USE OF THE VEST AND THE DEVELOPMENT OF A PLEURAL EFFUSION, IT WAS MOST LIKELY DUE TO HIS UNDERLYING DISEASE. THERE WAS NO EVIDENCE OF A MALFUNCTION AND THE DEVICE PERFORMED AS INTENDED. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.