Brand Name | HS1+ (W G) DEFIB, JAPANESE, EXCHG |
Type of Device | AED |
Manufacturer (Section D) |
PHILIPS NORTH AMERICA LLC |
22100 bothell everett highway |
bothell WA 98021 |
|
MDR Report Key | 12024191 |
MDR Text Key | 257168231 |
Report Number | 3030677-2021-11982 |
Device Sequence Number | 1 |
Product Code |
MKJ
|
UDI-Device Identifier | 00884838075849 |
UDI-Public | 00884838075849 |
Combination Product (y/n) | N |
PMA/PMN Number | P160029 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,foreign |
Type of Report
| Initial,Followup,Followup,Followup |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Other
|
Device Model Number | M5066A |
Device Catalogue Number | 453564508241 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 09/03/2021 |
Distributor Facility Aware Date | 05/26/2021 |
Initial Date Manufacturer Received |
05/26/2021 |
Initial Date FDA Received | 06/18/2021 |
Supplement Dates Manufacturer Received | 06/16/2021 07/20/2021 09/15/2021
|
Supplement Dates FDA Received | 07/15/2021 07/21/2021 09/16/2021
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|