Brand Name | HT50 VENTILATOR |
Type of Device | CONTINUOUS VENTILATOR |
Manufacturer (Section D) |
NEWPORT MEDICAL INSTRUMENTS, INC |
1620 sunflower ave. |
costa mesa CA 92626 |
|
Manufacturer (Section G) |
NEWPORT MEDICAL INSTRUMENTS, INC |
1620 sunflower ave. |
|
costa mesa CA 92626 |
|
Manufacturer Contact |
thom
mcnamara
|
15 hampshire street |
mansfield, MA 02048
|
5084524811
|
|
MDR Report Key | 5448897 |
MDR Text Key | 38633314 |
Report Number | 2023050-2016-00101 |
Device Sequence Number | 1 |
Product Code |
CBK
|
Combination Product (y/n) | N |
Reporter Country Code | HR |
PMA/PMN Number | K082724 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Service Personnel
|
Type of Report
| Initial |
Report Date |
01/25/2016 |
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? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | HT50 |
Device Catalogue Number | HT50-H1-B |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
01/25/2016 |
Initial Date FDA Received | 02/19/2016 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 03/01/2013 |
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 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 3 YR |
Patient Weight | 7 |
|
|