MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2000-10-05 for CARDIOLAB SYSTEM 210-00226-00 NA manufactured by Ge Marquette Medical Systems.
[15740495]
User facility reported that amplifier pacing channel malfunctioned during procedure necessitating bypass of amplifier and use of direct pacing channel for stimulation of pt. User facility reports there was no death or injury to pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2124823-2000-00047 |
| MDR Report Key | 300223 |
| Report Source | 05,06 |
| Date Received | 2000-10-05 |
| Date of Event | 2000-09-06 |
| Date Mfgr Received | 2000-09-06 |
| Device Manufacturer Date | 2000-03-01 |
| Date Added to Maude | 2000-10-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | KRISTEN PABST |
| Manufacturer Street | 8200 WEST TOWER AVE |
| Manufacturer City | MILWAUKEE WI 53223 |
| Manufacturer Country | US |
| Manufacturer Postal | 53223 |
| Manufacturer Phone | 4143622793 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARDIOLAB SYSTEM |
| Generic Name | 48 CHANNEL AMPLIFIER |
| Product Code | DRR |
| Date Received | 2000-10-05 |
| Returned To Mfg | 2000-09-08 |
| Model Number | 210-00226-00 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 287008 |
| Manufacturer | GE MARQUETTE MEDICAL SYSTEMS |
| Manufacturer Address | 8200 WEST TOWER AVE MILWAUKEE WI 53223 US |
| Baseline Brand Name | CARDIOLAB AMPLIFIER |
| Baseline Generic Name | AMPLIFIER |
| Baseline Model No | 210-00226-00 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | CARDIOLAB AMPLIFIER |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K001305 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-10-05 |