Brand Name | ECARECOMPANION |
Type of Device | ECAD BP MEDIUM/LG |
Manufacturer (Section D) |
VISICU, INC - DUP |
217 e redwood st ste 1900 |
baltimore MD 21202 |
|
Manufacturer (Section G) |
PHILIPS HEALTHCARE (ALPHARETTA) |
one deerfield center |
13560 morris road ste 2100 |
alpharetta GA 30004 |
|
Manufacturer Contact |
sharon
fishter
|
217 e redwood st ste 1900 |
baltimore, MD 21202
|
|
MDR Report Key | 9728684 |
MDR Text Key | 180760329 |
Report Number | 1125873-2020-00002 |
Device Sequence Number | 1 |
Product Code |
DRG
|
UDI-Device Identifier | 00884838084452 |
UDI-Public | (01)00884838084452 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K043217 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer,health professional |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
01/30/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Device Model Number | 453564551731 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/05/2020 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
01/22/2020 |
Initial Date FDA Received | 02/19/2020 |
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|