MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-07-08 for 767 INTEGRATED DIAGNOSTIC WALL SYSTEM 76792-M 76792-XXX manufactured by Welch Allyn, Inc..
[4851401]
Welch allyn received an initial report from a facility with an allegation that the wall transformer system, mounted over the bed, had been kicked upward at the base dislodging it from the wall mount. The device hit the patient's father, but did not injure him.
Patient Sequence No: 1, Text Type: D, B5
[12328908]
Welch allyn is reporting this event in an abundance of caution pending completion of the investigation. A follow-up report will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1316463-2014-00004 |
| MDR Report Key | 4063420 |
| Report Source | 05 |
| Date Received | 2014-07-08 |
| Date of Report | 2014-07-08 |
| Date of Event | 2014-06-09 |
| Date Mfgr Received | 2014-06-09 |
| Date Added to Maude | 2014-09-11 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | PEARLEY BHAMBRI, RA DIRECTOR |
| 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 | 767 INTEGRATED DIAGNOSTIC WALL SYSTEM |
| Generic Name | WALL TRANSFORMER |
| Product Code | GCW |
| Date Received | 2014-07-08 |
| Model Number | 76792-M |
| Catalog Number | 76792-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, INC. |
| Manufacturer Address | 4341 STATE ST. RD. P.O. BOX 220 SKANEATELES FALLS NY 13153022 US 13153 0220 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-07-08 |