Brand Name | HEARTSTART ONSITE |
Type of Device | AED |
Manufacturer (Section D) |
PHILIPS MEDICAL SYSTEMS |
22100 bothell everett hwy |
bothell WA 98021 8431 |
|
Manufacturer Contact |
shannon
decker
|
22100 bothell-everett hwy |
bldg a |
bothell, WA 98021-8431
|
8887445477
|
|
MDR Report Key | 7506965 |
MDR Text Key | 108108367 |
Report Number | 3030677-2018-01072 |
Device Sequence Number | 1 |
Product Code |
MLN
|
UDI-Device Identifier | 00884838075849 |
UDI-Public | (01)00884838075849 |
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | 020715 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,foreign |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
05/07/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 05/11/2018 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Other
|
Device Expiration Date | 10/30/2019 |
Device Model Number | M5066A |
Device Catalogue Number | 861282 |
Device Lot Number | Y041017-03 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 05/07/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 05/01/2017 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|