Brand Name | PIIC IX HARDWARE |
Type of Device | CENTRAL STATION MONITOR |
Manufacturer (Section D) |
PHILIPS MEDICAL SYSTEMS |
3000 minuteman road |
andover MA 01810 |
|
Manufacturer Contact |
betty
harris
|
3000 minuteman road |
andover, MA 01810
|
9786871501
|
|
MDR Report Key | 8964455 |
MDR Text Key | 156730409 |
Report Number | 1218950-2019-06692 |
Device Sequence Number | 1 |
Product Code |
MHX
|
UDI-Device Identifier | 00884838052130 |
UDI-Public | (01)00884838052130 |
Combination Product (y/n) | N |
Reporter Country Code | UK |
PMA/PMN Number | K102495 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,user facility |
Reporter Occupation |
Other Health Care Professional
|
Remedial Action |
Repair |
Type of Report
| Initial |
Report Date |
03/12/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 866424 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
03/12/2018 |
Initial Date FDA Received | 09/05/2019 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 02/08/2017 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Removal/Correction Number | Z-0776-2018 |
Patient Sequence Number | 1 |
|
|