MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-08-15 for FLOWTRON EXCEL / TRIO PUMPS 247001 manufactured by Getinge (suzhou) Co., Ltd..
[21673134]
Caregiver was shocked while attempting to plug in an ac550 in a dimly lit room. What had happened previously is that the warning tag on the plug was torn off, but the metal eyelet remained. The eyelet somehow contributed to the shock, getting into contact with the ground, etc. Facility rep states that they believe the device is functioning normally. Ac500 plug arced as caregiver plugged pump into approved hospital grade grounded electrical outlet. Caregiver received electrical shock, was evaluated at ed, an cleared with no injuries. Ref # 3005619970-2013-00009.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419652-2013-00215 |
| MDR Report Key | 3307756 |
| Date Received | 2013-08-15 |
| Date of Report | 2013-07-17 |
| Date of Event | 2013-07-16 |
| Date Facility Aware | 2013-07-17 |
| Report Date | 2013-08-14 |
| Date Added to Maude | 2013-08-27 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 Street | 50 NORTH GARY AVE., SUITE A |
| Manufacturer City | ROSELLE IL 601721684 |
| Manufacturer Country | US |
| Manufacturer Postal | 601721684 |
| Manufacturer G1 | ARJO, INC. |
| Manufacturer Street | 50 NORTH GARY AVE., SUITE A |
| Manufacturer City | ROSELLE IL 60172168 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60172 1684 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLOWTRON EXCEL / TRIO PUMPS |
| Product Code | KNM |
| Date Received | 2013-08-15 |
| Model Number | 247001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GETINGE (SUZHOU) CO., LTD. |
| Manufacturer Address | NO. 158 FANGZHOU ROAD, SIP SUZHOU, JIANGSU 215024 CH 215024 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-08-15 |