Brand Name | VITAL SIGNS HEAD POSITIONER |
Type of Device | SUPPORT, PATIENT POSITION |
Manufacturer (Section D) |
VYAIRE MEDICAL. |
26125 n. riverwoods blvd. |
mettawa, il |
|
Manufacturer (Section G) |
DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L. |
602 parkway, global park |
box 180-3006 |
la aurora, 146 |
CS
146
|
|
Manufacturer Contact |
mindy
faber
|
26125 n. riverwoods blvd. |
mettawa, il
|
7570116
|
|
MDR Report Key | 9771507 |
MDR Text Key | 189316781 |
Report Number | 9613793-2020-00009 |
Device Sequence Number | 1 |
Product Code |
CCX
|
Combination Product (y/n) | N |
Reporter Country Code | SP |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,user facility |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
01/30/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 02/28/2020 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | VITAL SIGNS¿ HEAD POSITIONER |
Device Catalogue Number | 8000HDP |
Device Lot Number | 49797348 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 01/30/2020 |
Was Device Evaluated by Manufacturer? |
No
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|