MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-04-21 for HEARTSTART HS2000 900000/900050 manufactured by Laerdal Medical A.s..
[446181]
During an incident in 2000 involving a patient this defibrillator analyzed, started to charge and then shut down prompting "battery??? " (not sure of the exact prompt). A second battery was tried and the same thing happened 6 times, the unit shut down with a prompt. A couple of times they saw a "service mandatory" message. Als arrived and shocked the patient. The patient was pronouced.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610483-2006-00083 |
| MDR Report Key | 702731 |
| Report Source | 06 |
| Date Received | 2006-04-21 |
| Date of Report | 2000-05-04 |
| Date of Event | 2000-04-27 |
| Date Facility Aware | 2000-04-27 |
| Report Date | 2000-05-04 |
| Date Mfgr Received | 2000-05-04 |
| Date Added to Maude | 2006-04-25 |
| 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 | WAPPINGENS 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 | NKJ |
| Date Received | 2006-04-21 |
| Returned To Mfg | 2000-05-10 |
| Model Number | HS2000 |
| Catalog Number | 900000/900050 |
| Lot Number | NA |
| ID Number | 510K#K860676/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | UNK |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 691861 |
| Manufacturer | LAERDAL MEDICAL A.S. |
| Manufacturer Address | * STAVANGER NO |
| Baseline Brand Name | HEARTSTART |
| Baseline Generic Name | SAED |
| Baseline Model No | HS2000 |
| Baseline Catalog No | 900000/900050 |
| Baseline ID | 510K# K60676/A |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-04-21 |