Brand Name | HUDSON ISO-GARD HEPA LIGHT,CLEAN |
Type of Device | FILTER, BACTERIAL, BREATHING-C |
Manufacturer (Section D) |
TELEFLEX MEDICAL |
perak, west malaysia |
|
MDR Report Key | 7822772 |
MDR Text Key | 118550632 |
Report Number | 8040412-2018-00223 |
Device Sequence Number | 1 |
Product Code |
CAH
|
Combination Product (y/n) | N |
PMA/PMN Number | K954828 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Type of Report
| Initial,Followup |
Report Date |
08/10/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 08/28/2018 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Catalogue Number | 28022 |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 10/05/2018 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Treatment | SERVO 1 VENTILATOR, 880-36KIT CIRCUIT[HUDSON].; SERVO 1 VENTILATOR, 880-36KIT CIRCUIT[HUDSON]. |
|
|