MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-20 for CHANGE HEALTHCARE CARDIOLOGY ECG MANAGMENT 14.1.1 manufactured by Mckesson Israel Ltd..
| Report Number | 9616760-2020-00001 |
| MDR Report Key | 9731293 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-20 |
| Date of Report | 2020-02-20 |
| Date of Event | 2019-10-23 |
| Date Mfgr Received | 2019-10-30 |
| Device Manufacturer Date | 2019-01-16 |
| Date Added to Maude | 2020-02-20 |
| 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 | MR CHESTER MCCOY |
| Manufacturer Street | 5995 WINDWARD PARKWAY |
| Manufacturer City | ALPHARETTA, GA |
| Manufacturer Country | US |
| Manufacturer Phone | 3382088 |
| Manufacturer G1 | MCKESSON ISRAEL LTD. |
| Manufacturer Street | 26 HAROKMIM ST. AZRIELI CENTER BUILDING A |
| Manufacturer City | HOLON, 5885849 |
| Manufacturer Country | IS |
| Manufacturer Postal Code | 5885849 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHANGE HEALTHCARE CARDIOLOGY ECG MANAGMENT |
| Generic Name | CHANGE HEALTHCARE CARDIOLOGY ECG MANAGMENT |
| Product Code | DQK |
| Date Received | 2020-02-20 |
| Model Number | 14.1.1 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MCKESSON ISRAEL LTD. |
| Manufacturer Address | 26 HAROKMIM ST. AZRIELI CENTER BUILDING A HOLON, 5885849 IS 5885849 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-20 |