MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2005-09-30 for HEARTSTART HS3000QR 920054 manufactured by Laerdal Medical A/s.
[15184910]
A pt experienced chest pains while skiing. The crew unsuccessfully attempted to power-on a defibrillator about 50 times. The pt was transported to a hosp. The pt experienced trigeminal pvc's which went away after oxygen was administered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610483-2005-00079 |
| MDR Report Key | 638636 |
| Report Source | 06 |
| Date Received | 2005-09-30 |
| Date of Report | 2003-03-11 |
| Date of Event | 2003-03-09 |
| Date Facility Aware | 2003-03-09 |
| Report Date | 2003-03-11 |
| Date Mfgr Received | 2003-03-11 |
| Device Manufacturer Date | 1993-09-01 |
| Date Added to Maude | 2005-10-03 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | LINDA RIEDEBURG |
| Manufacturer Street | 167 MYERS CORNERS ROAD |
| Manufacturer City | WAPPINGERS FALLS NY 125908840 |
| Manufacturer Country | US |
| Manufacturer Postal | 125908840 |
| Manufacturer Phone | 8452977770 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEARTSTART |
| Generic Name | SAED |
| Product Code | MKT |
| Date Received | 2005-09-30 |
| Returned To Mfg | 2003-03-19 |
| Model Number | HS3000QR |
| Catalog Number | 920054 |
| Lot Number | 9309 |
| ID Number | 510K#K896919 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 9 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 628185 |
| Manufacturer | LAERDAL MEDICAL A/S |
| Manufacturer Address | * STAVANGER NO |
| Baseline Brand Name | HEARTSTART |
| Baseline Generic Name | SAED |
| Baseline Model No | HS3000QR |
| Baseline Catalog No | 920054 |
| Baseline ID | 510K#K896919 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-09-30 |