MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-12 for HEARTSINE SAMARITAN 300P AND PAD-PAK UNK_BEL manufactured by Heartsine Technologies Ltd.
[126972307]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[126972308]
Device switching on automatically. No patient involved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004123209-2018-00700 |
| MDR Report Key | 8059141 |
| Date Received | 2018-11-12 |
| Date of Report | 2018-11-12 |
| Date of Event | 2018-10-01 |
| Date Mfgr Received | 2018-10-31 |
| Date Added to Maude | 2018-11-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 |
| Removal Correction Number | Z-0124-2013 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HEARTSINE SAMARITAN 300P AND PAD-PAK |
| Generic Name | AUTOMATED EXTERNAL DEFIBRILLATOR |
| Product Code | MJK |
| Date Received | 2018-11-12 |
| Catalog Number | UNK_BEL |
| 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 | 2018-11-12 |