MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-26 for ONESTEP 8900-0224-01 manufactured by Bio-detek Incorporated.
[106608534]
Patient Sequence No: 1, Text Type: N, H10
[106608535]
Biomed was notified that the adult electrode pad does not align correctly as depicted on the photo on the device packaging. The instructions are not accurate to the actual layout to the actual pad. Approximately one inch between the image instructions and pad versus the one step pad that is preassembled. No direction or perforation indicating that the user should manually separate and realign the pads (blue #2 - two part front chest pad). The instruction informs the user to line up the bottom of the dark blue upper portion of the blue triangle and the red cross line of the compression puck to the nipple line of the patient. When the user aligns the pad as directed, the pad is in the wrong place for optimal compressions.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7463893 |
| MDR Report Key | 7463893 |
| Date Received | 2018-04-26 |
| Date of Report | 2018-04-18 |
| Date of Event | 2018-04-12 |
| Report Date | 2018-04-18 |
| Date Reported to FDA | 2018-04-18 |
| Date Reported to Mfgr | 2018-04-18 |
| Date Added to Maude | 2018-04-26 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ONESTEP |
| Generic Name | AID, CARDIOPULMONARY RESUSCITATION |
| Product Code | LIX |
| Date Received | 2018-04-26 |
| Model Number | 8900-0224-01 |
| Catalog Number | 8900-0224-01 |
| Lot Number | 3816A |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIO-DETEK INCORPORATED |
| Manufacturer Address | 525 NARRAGANSETT PARK DR. PAWTUCKET RI 02861 US 02861 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-26 |