MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-02-20 for CHANGE HEALTHCARE CARDIOLOGY HEMO 14.1.1 manufactured by Change Healthcare Israel Ltd.
[180096750]
The reporting facility stated that the device did not cause or contribute to the death of the patient. Initial investigation revealed the root cause of the reported malfunction is associated with the hardware components of the device. The hardware components were replaced, and then monitored by the reporting facility. The reporting facility confirmed the rt monitor is working as designed since the replacement. The hardware associated with the failure is under further investigation. Change healthcare will provide a follow up report to the agency once additional information is available.
Patient Sequence No: 1, Text Type: N, H10
[180096751]
It was reported that during a procedure in the catheterization lab involving a patient in full cardiac arrest undergoing cpr, defibrillation, and artificial ventilation, that the rt monitor went blank multiple times and rebooted for several seconds and returned to full functionality. During the procedure and the reported rt monitor blanking out events, as indicated in the device instructions for use auxiliary devices were used to monitor the patient's vital signs. Subsequent to the procedure the patient expired.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616760-2020-00002 |
| MDR Report Key | 9731301 |
| Report Source | OTHER |
| Date Received | 2020-02-20 |
| Date of Report | 2020-02-20 |
| Date of Event | 2020-01-22 |
| Date Mfgr Received | 2020-01-22 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | CHANGE HEALTHCARE ISRAEL LTD. |
| Manufacturer Street | 26 HAROKMIM ST. AZRIELI CENTER BUILDING A |
| Manufacturer City | HOLON HAMERKAZ, ISRAEL 5885849 |
| Manufacturer Country | IS |
| Manufacturer Postal Code | 5885849 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHANGE HEALTHCARE CARDIOLOGY HEMO |
| Generic Name | CHANGE HEALTHCARE CARDIOLOGY HEMO |
| Product Code | DQK |
| Date Received | 2020-02-20 |
| Returned To Mfg | 2020-01-28 |
| Model Number | 14.1.1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHANGE HEALTHCARE ISRAEL LTD |
| Manufacturer Address | 26 HAROKMIM ST. AZRIELI CENTER BUILDING A HOLON HAMERKAZ, ISRAEL 5885849 IS 5885849 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-02-20 |