MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-10-17 for RENASYS GO POWER SUPPLY 66800161 manufactured by Smith & Nephew, Inc..
[57574929]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[57574930]
Arcing it was reported whilst plugging in the new power pack , one of our pnps received an electric shock. When the unit was returned to the rep she also tried to plug the unit and received an electric shock.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006760724-2016-00156 |
| MDR Report Key | 6033029 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-10-17 |
| Date of Report | 2017-07-14 |
| Date of Event | 2016-10-06 |
| Date Mfgr Received | 2016-10-10 |
| Date Added to Maude | 2016-10-17 |
| 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 CLAUDIA ODOY |
| Manufacturer Street | SCHACHENALLEE 29 |
| Manufacturer City | AARAU 5001 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 5001 |
| Manufacturer Phone | 0628320660 |
| Manufacturer G1 | SMITH & NEPHEW ENDOSCOPY |
| Manufacturer Street | 76. S MERIDAN AVENUE |
| Manufacturer City | OKLAHOMA CITY OK 73107 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 73107 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RENASYS GO POWER SUPPLY |
| Generic Name | PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) |
| Product Code | BTA |
| Date Received | 2016-10-17 |
| Model Number | 66800161 |
| Catalog Number | 66800161 |
| Lot Number | 144701649 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 970 LAKE CARILLON DRIVE ST PETERSBURG FL 33716 US 33716 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-17 |