Brand Name | MULTI-LINK¿ ADAPTER |
Type of Device | CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR) |
Manufacturer (Section D) |
VYAIRE MEDICAL OY |
kuortaneenkatu 2 helsinki ete |
la-suomen laani, |
helsinki |
FI |
|
Manufacturer (Section G) |
CARLISLE MEDICAL TECHNOLOGIES (DONGGUAN) CO., LTD |
no.2 xinhu industrial park, de |
ngwu village, qiaotou town |
dongguan 52353 3 |
CH
523533
|
|
Manufacturer Contact |
erika
bonilla
|
510 technology drive |
irvine, CA 92618
|
|
MDR Report Key | 17145063 |
MDR Text Key | 317345522 |
Report Number | 3010838917-2023-00065 |
Device Sequence Number | 1 |
Product Code |
DSA
|
UDI-Device Identifier | 10190752138155 |
UDI-Public | (01)10190752138155 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K980582 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
User Facility |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial,Followup |
Report Date |
06/16/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 06/16/2023 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | TELE ADAPTER X2, 5/6-LEAD FOR APEXPRO FH |
Device Catalogue Number | 2090101-110 |
Device Lot Number | NOT PROVIDED |
Was Device Available for Evaluation? |
Yes
|
Date Manufacturer Received | 06/29/2023 |
Was Device Evaluated by Manufacturer? |
No
|
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 |
|
|