MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-06-29 for IVAC 4200 VITALCHECK * manufactured by Alaris Medical Systems.
[423449]
An ivac vital sign machine was noted to have smoke emanating from it in a patient's room. The device was not plugged into a power outlet at the time of the event. The device was standing free in the patient's room, no part of the device was attached to the patient at the time of the event. Biomed evaluated the device and found that the plastic covering of the 6 "d" sized battery pack appeared to be melted. Biomed replaced the battery pack and the vital signs monitor ran fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 620592 |
| MDR Report Key | 620592 |
| Date Received | 2005-06-29 |
| Date of Report | 2005-06-29 |
| Date of Event | 2005-05-02 |
| Report Date | 2005-06-29 |
| Date Reported to FDA | 2005-06-29 |
| Date Added to Maude | 2005-07-13 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IVAC 4200 VITALCHECK |
| Generic Name | VITAL SIGNS MONITOR |
| Product Code | DXN |
| Date Received | 2005-06-29 |
| Model Number | 4200 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 610277 |
| Manufacturer | ALARIS MEDICAL SYSTEMS |
| Manufacturer Address | 10221 WATERIDGE CIRCLE SAN DIEGO CA 92121 US |
| Baseline Brand Name | MULTIPLE VITAL SIGNS UNIT |
| Baseline Generic Name | VITAL SIGNS MONITOR |
| Baseline Model No | 4200 |
| Baseline Catalog No | 4200 |
| Baseline ID | NA |
| Baseline Device Family | VITAL SIGNS MONITOR |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K820569 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Brand Name | CYCLON |
| Generic Name | BATTERY PACK |
| Product Code | MOX |
| Date Received | 2005-06-29 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | 1 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 2 |
| Device Event Key | 610278 |
| Manufacturer | HAWKER ENERGY |
| Manufacturer Address | 617 NORTH RIDGE VIEW DRIVE WARRENSBURG MO 64093 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-06-29 |