Brand Name | ADULT ULTRA FLEX ANESTHESIA BREATHING CIRCUIT |
Type of Device | ANESTHESIA BREATHING CIRCUIT |
Manufacturer (Section D) |
KING SYSTEMS |
15011 herriman blvd. |
noblesvill IN 46060 |
|
Manufacturer (Section G) |
KING SYSTEMS |
15011 herriman blvd. |
|
noblesville IN 46060 |
|
Manufacturer Contact |
wayne
nethercutt
|
15011 herriman blvd. |
noblesville, IN 46060
|
3177763175
|
|
MDR Report Key | 6552199 |
MDR Text Key | 74705115 |
Report Number | 1824226-2017-00002 |
Device Sequence Number | 1 |
Product Code |
CAI
|
UDI-Device Identifier | 00612649204673 |
UDI-Public | (01)00612649204673 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K983817 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
user facility |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
04/26/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 05/08/2017 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Model Number | KN6903B-6121Z |
Device Catalogue Number | KN6903B-6121Z |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 03/28/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|