MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2020-03-30 for POWERHEART G5 KIT, SEMI, UK G5S-02A manufactured by Cardiac Science Corporation.
[188690812]
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
[188690813]
Complainant alleged that during functional testing, the device displayed an "ecg fault-501" error message. Complainant did not indicate that there was any patient involvement in the reported malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2112020-2020-00211 |
| MDR Report Key | 9898635 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-09 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2018-09-18 |
| Date Added to Maude | 2020-03-30 |
| 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 | POWERHEART G5 KIT, SEMI, UK |
| Generic Name | AUTOMATED EXTERNAL DEFIBRILLATOR |
| Product Code | MKJ |
| Date Received | 2020-03-30 |
| Model Number | G5S-02A |
| Catalog Number | G5S-02A |
| 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 | 2020-03-30 |