N
Patient 1
WELCH ALLYN IS REPORTING THIS EVENT IN AN ABUNDANCE OF CAUTION. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
MAUDE MDR 5130045
- MDR report key
- 5130045
- Report number
- 1316463-2015-00043
- Event key
- 0
- Event type
- 3
- Date of event
- 2015-09-09
- Date received
- 2015-10-06
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 2
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MRS. LAUREN NEUBAUER
- Address
- 4341 STATE STREET ROAD P.O. BOX 220 SKANEATELES FALLS NY 13153 US
- Phone
- 315-315-3156
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | GREEN SERIES 777 INTEGRATED WALL SYSTEM | WALL TRANSFORMER | WELCH ALLYN | HMF | 77710 | 77710-XXX | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-10-06 | 0 |
Event Narratives#
D
Patient 1
WELCH ALLYN RECEIVED A REPORT FROM A HOSPITAL WITH THE ALLEGATION THAT A SURGEON WAS IN THE PROCESS OF RAISING THE BED IN A PATIENT ROOM THAT WAS NOT IN CLINICAL USE WHEN THE BED CAME IN CONTACT WITH THE INTEGRATED WALL PANEL. THE INTEGRATED WALL PANEL LIFTED OFF OF THE WALL MOUNTED RAIL BRACKET, ALLOWING THE PANEL TO DROP ONTO THE BED. THERE WAS NO PATIENT INVOLVED IN THE EVENT. THIS OCCURRED IN A PATIENT ROOM THAT WAS NEW AND NOT YET IN CLINICAL USE. NO ONE WAS HURT OR INJURED IN THE EVENT. THE PANEL CONTAINED AN ANEROID BLOOD PRESSURE GAUGE AND CUFF, WALL TRANSFORMER, SPECULA DISPENSER AND THERMOMETER, EACH MOUNTED TO THE PANEL. THE FALLEN PANEL SUSTAINED PHYSICAL DAMAGE TO THE CORNER OF THE PANEL AND THE WALL TRANSFORMER.
N
Patient 1
THE ACTUAL DEVICE WAS NOT RETURNED TO WELCH ALLYN FOR EVALUATION. PHOTOS OF THE DEVICE AND THE MOUNTING WERE PROVIDED BY THE CUSTOMER. ENGINEERING CONCLUDED THAT AN UPWARD FORCE PLACED ON THE WALL PANEL IS THE MOST LIKELY CAUSE FOR THE WALL TRANSFORMER BOARD FALLING OFF THE WALL. THE INVESTIGATION HAS DETERMINED THERE IS NO EVIDENCE OF A MANUFACTURING DEFECT. (B)(4).