Brand Name | XHIBIT CENTRAL STATION |
Type of Device | XHIBIT CENTRAL STATION REMOTE MONITOR |
Manufacturer (Section D) |
SPACELABS HEALTHCARE |
35301 se center st |
snoqualmie WA 98065 |
|
Manufacturer (Section G) |
SPACELABS HEALTHCARE |
35301 se center st |
|
snoqualmie WA 98065 |
|
Manufacturer Contact |
whitney
snyder
|
35301 se center st |
snoqualmie, WA 98065
|
|
MDR Report Key | 19218311 |
MDR Text Key | 341500310 |
Report Number | 3010157426-2024-00068 |
Device Sequence Number | 1 |
Product Code |
MHX
|
UDI-Device Identifier | 10841522100345 |
UDI-Public | 011084152210034511161227 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K122146 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
04/11/2024 |
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 | 96102 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/11/2024 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
04/11/2024
|
Initial Date FDA Received | 04/30/2024 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 12/28/2016 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |