MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-10-10 for HEARTSINE SAMARITAN 500P AND PAD-PAK 80515-000040 manufactured by Heartsine Technologies Ltd.
[123202132]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[123202133]
Device service required prompt heard. There was no patient involved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004123209-2018-00622 |
| MDR Report Key | 7950720 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-10-10 |
| Date of Report | 2018-10-10 |
| Date of Event | 2018-09-01 |
| Date Mfgr Received | 2018-09-25 |
| Date Added to Maude | 2018-10-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. CAROLINE KIRWAN |
| Manufacturer Street | 203 AIRPORT ROAD WEST |
| Manufacturer City | BELFAST BT3 9ED |
| Manufacturer Postal | BT3 9ED |
| Manufacturer Phone | 2890939400 |
| Manufacturer G1 | HEARTSINE TECHNOLOGIES LTD |
| Manufacturer Street | 203 AIRPORT ROAD WEST |
| Manufacturer City | BELFAST BT3 9ED |
| Manufacturer Postal Code | BT3 9ED |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEARTSINE SAMARITAN 500P AND PAD-PAK |
| Generic Name | AUTOMATED EXTERNAL DEFIBRILLATOR |
| Product Code | MKJ |
| Date Received | 2018-10-10 |
| Catalog Number | 80515-000040 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | HEARTSINE TECHNOLOGIES LTD |
| Manufacturer Address | 203 AIRPORT ROAD WEST BELFAST BT3 9ED BT3 9ED |
| Brand Name | HEARTSINE SAMARITAN 500P AND PAD-PAK |
| Generic Name | AUTOMATED EXTERNAL DEFIBRILLATOR |
| Product Code | MJK |
| Date Received | 2018-10-10 |
| Catalog Number | 80515-000040 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HEARTSINE TECHNOLOGIES LTD |
| Manufacturer Address | 203 AIRPORT ROAD WEST BELFAST BT3 9ED BT3 9ED |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-10 |