MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-05-30 for GREEN SERIES 777 INTEGRATED WALL SYSTEM 77710 77710-XXX manufactured by Welch Allyn.
[4606433]
Welch received an initial report from a facility with an allegation of the wall transformer system, mounted near the head of the bed, had fallen off the wall. The weight of the mount caused it to fall forward and strike a pt in the head. The pt presented with a minor soft tissue injury with no fractures.
Patient Sequence No: 1, Text Type: D, B5
[12060196]
Welch allyn is reporting this event in an abundance of caution as it is unclear whether the device or incorrect installation of the device or some other factor caused the event. A f/u report will be submitted when the eval is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1316463-2014-00003 |
| MDR Report Key | 3961373 |
| Report Source | 05 |
| Date Received | 2014-05-30 |
| Date of Report | 2014-05-29 |
| Date of Event | 2014-05-02 |
| Date Mfgr Received | 2014-05-02 |
| Date Added to Maude | 2014-08-01 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | PEARLEY BHAMBRI, DIR |
| Manufacturer Street | 4341 STATE ST. RD. P.O. BOX 220 |
| Manufacturer City | SKANEATELES FALLS NY 131530220 |
| Manufacturer Country | US |
| Manufacturer Postal | 131530220 |
| Manufacturer Phone | 3156852568 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GREEN SERIES 777 INTEGRATED WALL SYSTEM |
| Generic Name | WALL TRANSFORMER, 86H-MF |
| Product Code | HMF |
| Date Received | 2014-05-30 |
| 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 ST. RD. SKANEATELES FALLS NY 13153 US 13153 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-05-30 |