MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2008-07-25 for SILHOUETTE 20 HF B3115NG NA manufactured by Ge Medical Systems, Llc.
[876938]
It was reported that the table locks did not actuate, causing the tabletop to move in two axes without resistance. There was neither pt involvement nor injury reported. This situation could potentially contribute to a serious injury if a pt were to become unsteady and fall.
Patient Sequence No: 1, Text Type: D, B5
[7884739]
The problem was discovered during a ge field engineer's (fe) maintenance of a different equipment. The fe evaluated the system and found a failed resistor that prevented the table locks from engaging, thus simulating a table float commend. The fe replaced resistor and verified that the table locks were performing according to specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2126677-2008-00053 |
| MDR Report Key | 1081561 |
| Report Source | 07 |
| Date Received | 2008-07-25 |
| Date of Report | 2008-05-11 |
| Date of Event | 2008-05-11 |
| Date Mfgr Received | 2008-05-11 |
| Device Manufacturer Date | 1998-07-01 |
| Date Added to Maude | 2009-01-22 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARTHA KAMROW |
| Manufacturer Street | 3000 N GRANDVIEW BLVD. |
| Manufacturer City | WAUKESHA WI 53188 |
| Manufacturer Country | US |
| Manufacturer Postal | 53188 |
| Manufacturer Phone | 2623127196 |
| Manufacturer G1 | GE MEDICAL SYSTEMS, LLC |
| Manufacturer Street | 3000 N GRANDVIEW BLVD. |
| Manufacturer City | WAUKESHA WI 53188 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53188 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SILHOUETTE 20 HF |
| Product Code | IZO |
| Date Received | 2008-07-25 |
| Model Number | B3115NG |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE MEDICAL SYSTEMS, LLC |
| Manufacturer Address | 3000 N GRANDVIEW BLVD. WAUKESHA WI 53188 US 53188 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-07-25 |