MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-07-11 for PHYSIO CONTROL LP 10 NA manufactured by Medtronic.
[391803]
Nursing home patient found by ems in full arrest in asystole. Lp10 used with combo pads. Staff was unable to get pacer to function. Unclear as to what lead select was used during pacing event. If on paddle, select pacer will not function normally. Monitor works appropriately after event, unclear as to user error or equipment error. Preventive maintenance done by medtronic staff on 07-2005.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 621108 |
| MDR Report Key | 621108 |
| Date Received | 2005-07-11 |
| Date of Report | 2005-07-07 |
| Date of Event | 2005-07-05 |
| Date Facility Aware | 2005-07-07 |
| Report Date | 2005-07-11 |
| Date Reported to FDA | 2005-07-11 |
| Date Reported to Mfgr | 2005-07-11 |
| Date Added to Maude | 2005-07-15 |
| 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 | 3 |
| 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 | PHYSIO CONTROL |
| Generic Name | LP 10 DEFIBRILLATOR/MONITOR/PACER |
| Product Code | DRK |
| Date Received | 2005-07-11 |
| Model Number | LP 10 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 10 YR |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 610754 |
| Manufacturer | MEDTRONIC |
| Manufacturer Address | 11811 WILLOW RD. NORTHEAST REDMOND WA 98073* US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-07-11 |