MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-07 for SCALETRONIX / WELCH ALLYN PEDIATRIC SCALE 4802 manufactured by Welch Allyn.
[94194807]
A review of welch allyn post market surveillance data from (b)(6) 2015 to the present shows no previous complaint for this incident. The device has not been returned for investigation due to the pending litigation. If welch allyn becomes aware of additional information a follow up report will be filed. This mdr is filed in an abundance of caution due to the serious injury.
Patient Sequence No: 1, Text Type: N, H10
[94194808]
Welch allyn received litigation regarding an alleged incident that occurred on (b)(6) 2015 at (b)(6) medical center in (b)(6). The complaint alleges that a nurse, received a shock from the power cord of a scale-tronix pediatric scale. The nurse, while attempting to weigh a (b)(6)-day old infant, noticed that the scale display was not functioning. The nurse returned the infant to the mother and reached to adjust the power cord of the pediatric scale when she immediately felt a shock to her right side and was thrown back approximately 12 feet, striking her head and losing consciousness. The nurse was seen in the emergency department and diagnosed with ecg abnormalities and a tbi (traumatic brain injury).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1316463-2017-00009 |
| MDR Report Key | 7097437 |
| Date Received | 2017-12-07 |
| Date of Report | 2017-11-09 |
| Date of Event | 2015-10-10 |
| Date Mfgr Received | 2017-11-20 |
| Date Added to Maude | 2017-12-07 |
| 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 | MR. EDWARD O'NEIL |
| Manufacturer Street | 4341 STATE STREET ROAD |
| Manufacturer City | SKANEATELES FALLS NY 131530220 |
| Manufacturer Country | US |
| Manufacturer Postal | 131530220 |
| Manufacturer Phone | 3155544055 |
| Manufacturer G1 | WELCH ALLYN |
| Manufacturer Street | 4341 STATE STREET ROAD P.O.BOX 220 |
| Manufacturer City | SKANEATELES FALLS NY 131530220 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 131530220 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SCALETRONIX / WELCH ALLYN PEDIATRIC SCALE |
| Generic Name | PEDIATRIC / INFANT SCALE |
| Product Code | FRW |
| Date Received | 2017-12-07 |
| Model Number | 4802 |
| Operator | NURSE |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WELCH ALLYN |
| Manufacturer Address | 4341 STATE STREET ROAD P.O.BOX 220 SKANEATELES FALLS NY 131530220 US 131530220 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Deathisabilit | 2017-12-07 |