MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 1998-01-06 for CGS SHUTTLE (TRANSEND) 551555 manufactured by Sensormedics Corp..
[74137]
After replacing the battery pack, the shuttle began smoking. There were no injuries or pt involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2050001-1998-00001 |
| MDR Report Key | 142228 |
| Report Source | 05,06,07 |
| Date Received | 1998-01-06 |
| Date of Report | 1998-01-05 |
| Date of Event | 1997-12-08 |
| Date Mfgr Received | 1997-12-08 |
| Device Manufacturer Date | 1989-07-01 |
| Date Added to Maude | 1998-01-12 |
| 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 | 0 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CGS SHUTTLE (TRANSEND) |
| Generic Name | CUTANOUS GAS MONITOR |
| Product Code | LPP |
| Date Received | 1998-01-06 |
| Returned To Mfg | 1997-12-30 |
| Model Number | NA |
| Catalog Number | 551555 |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 138724 |
| Manufacturer | SENSORMEDICS CORP. |
| Manufacturer Address | 22705 SAVI RANCH PKWY. YORBA LINDA CA 928874645 US |
| Baseline Brand Name | CGS SHUTTLE (TRANSEND) |
| Baseline Generic Name | CUTANEOUS GAS MONITOR |
| Baseline Model No | NA |
| Baseline Catalog No | 551555 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-01-06 |