MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-06 for GREEN SERIES 777 INTEGRATED WALL SYSTEM 77710 77710-XXX manufactured by Welch Allyn.
[28055111]
Welch allyn is reporting this event in an abundance of caution. A follow up report will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[28055112]
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.
Patient Sequence No: 1, Text Type: D, B5
[33165293]
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).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1316463-2015-00043 |
| MDR Report Key | 5130045 |
| Date Received | 2015-10-06 |
| Date of Report | 2015-09-09 |
| Date of Event | 2015-09-09 |
| Date Mfgr Received | 2015-11-23 |
| Date Added to Maude | 2015-10-06 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. LAUREN NEUBAUER |
| Manufacturer Street | 4341 STATE STREET ROAD P.O. BOX 220 |
| Manufacturer City | SKANEATELES FALLS NY 131530220 |
| Manufacturer Country | US |
| Manufacturer Postal | 131530220 |
| Manufacturer Phone | 3156853674 |
| Manufacturer G1 | WELCH ALLYN |
| Manufacturer Street | 4341 STATE STREET ROAD |
| Manufacturer City | SKANEATELES FALLS NY 13153 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 13153 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GREEN SERIES 777 INTEGRATED WALL SYSTEM |
| Generic Name | WALL TRANSFORMER |
| Product Code | HMF |
| Date Received | 2015-10-06 |
| Model Number | 77710 |
| Catalog Number | 77710-XXX |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WELCH ALLYN |
| Manufacturer Address | 4341 STATE STREET ROAD SKANEATELES FALLS NY 13153 US 13153 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-06 |