MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2007-02-13 for SHAMPAINE 5100B * manufactured by Getinge Usa, Inc., F.k.a. Mdt Diagnostic Co..
[18241023]
The nurse was placing the electrical plug into the appliance inlet and received a shock.
Patient Sequence No: 1, Text Type: D, B5
[18391122]
The appliance inlet at the base of the table was broken and taped together rather than fixed or replaced.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3019090-2007-00001 |
| MDR Report Key | 838262 |
| Report Source | 05,07 |
| Date Received | 2007-02-13 |
| Date of Report | 2007-01-31 |
| Date of Event | 2007-01-31 |
| Date Mfgr Received | 2007-02-05 |
| Device Manufacturer Date | 1998-08-01 |
| Date Added to Maude | 2007-04-18 |
| 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 | 0 |
| Manufacturer Contact | MS. LORRY CORDARO |
| Manufacturer Street | 1777 E. HENRIETTA ROAD |
| Manufacturer City | ROCHESTER NY 14623 |
| Manufacturer Country | US |
| Manufacturer Postal | 14623 |
| Manufacturer Phone | 5854751400 |
| Manufacturer G1 | GETINGE USA, INC. FKA MDT DIAGNOSITIC CO. |
| Manufacturer Street | 7371 SPARTAN BLVD. E. |
| Manufacturer City | N. CHARLESTON SC 29418 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 29418 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHAMPAINE |
| Generic Name | LWG |
| Product Code | LWG |
| Date Received | 2007-02-13 |
| Model Number | 5100B |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 825566 |
| Manufacturer | GETINGE USA, INC., F.K.A. MDT DIAGNOSTIC CO. |
| Manufacturer Address | * NORTH CHARLESTON SC * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-02-13 |