MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-25 for ELECTRODE ONESTEP CPR A/A GC, SINGLE 8900-000251-05 manufactured by Bio-detek Incorporated.
[143426957]
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Patient Sequence No: 1, Text Type: N, H10
[143426958]
Complainant alleged that during biomed testing, the associated the device was unable to obtain an ecg signal via attached electrode pads. Complainant indicated that there was no patient involvement in the reported malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1218058-2019-00038 |
| MDR Report Key | 8552516 |
| Date Received | 2019-04-25 |
| Date of Report | 2019-04-04 |
| Date Mfgr Received | 2019-04-04 |
| Device Manufacturer Date | 2018-06-04 |
| Date Added to Maude | 2019-04-25 |
| 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 Street | 525 NARRAGANSETT PARK DRIVE |
| Manufacturer City | PAWTUCKET RI 02861 |
| Manufacturer Country | US |
| Manufacturer Postal | 02861 |
| Manufacturer Phone | 4017291400 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ELECTRODE ONESTEP CPR A/A GC, SINGLE |
| Generic Name | ELECTRODE |
| Product Code | DRX |
| Date Received | 2019-04-25 |
| Returned To Mfg | 2019-04-30 |
| Model Number | 8900-000251-05 |
| Catalog Number | 8900-000251-05 |
| Lot Number | 2318 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIO-DETEK INCORPORATED |
| Manufacturer Address | 525 NARRAGANSETT PARK DRIVE PAWTUCKET RI 02861 US 02861 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-25 |