MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-31 for G3 PLUS AUTO, AED, AHA 2010, US ENGLISH 9390A-1001 manufactured by Cardiac Science Corporation.
[188526054]
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
[188526055]
Complainant alleged that during functional testing, the device was unable to obtain an ecg signal via pads. Complainant indicated that there was no patient involvement in the reported malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2112020-2020-00199 |
| MDR Report Key | 9903654 |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-10 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2014-05-27 |
| Date Added to Maude | 2020-03-31 |
| 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 | 269 MILL ROAD |
| Manufacturer City | CHELMSFORD MA 01824 |
| Manufacturer Country | US |
| Manufacturer Postal | 01824 |
| Manufacturer Phone | 9784219552 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | G3 PLUS AUTO, AED, AHA 2010, US ENGLISH |
| Generic Name | AUTOMATED EXTERNAL DEFIBRILLATOR |
| Product Code | MKJ |
| Date Received | 2020-03-31 |
| Model Number | 9390A-1001 |
| Catalog Number | 9390A-1001 |
| Lot Number | NA |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDIAC SCIENCE CORPORATION |
| Manufacturer Address | 500 BURDICK PARKWAY DEERFIELD WI 535319692 US 535319692 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |