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 |