MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-12-27 for SAPPHIRE EXTERNAL BATTERY PACK 15079-111-0001-P2 manufactured by Q Core Medical Ltd..
[131485847]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[131485848]
The event was reported by a customer from the usa: external battery pack overheating due to possible user error.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010293992-2018-00124 |
| MDR Report Key | 8198948 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-12-27 |
| Date of Report | 2018-11-29 |
| Date Facility Aware | 2018-11-29 |
| Date Added to Maude | 2018-12-27 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. JUDITH ANTLER |
| Manufacturer Street | YAD HARUZIM |
| Manufacturer City | NETANYA, 4250529 |
| Manufacturer Country | IS |
| Manufacturer Postal | 4250529 |
| Manufacturer G1 | Q CORE MEDICAL LTD. |
| Manufacturer Street | YAD HARUZIM |
| Manufacturer City | NETANYA, 4250529 |
| Manufacturer Country | IS |
| Manufacturer Postal Code | 4250529 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SAPPHIRE EXTERNAL BATTERY PACK |
| Generic Name | EXTERNAL BATTERY PACK |
| Product Code | MRZ |
| Date Received | 2018-12-27 |
| Catalog Number | 15079-111-0001-P2 |
| Lot Number | 0215 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Age | 5 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | Q CORE MEDICAL LTD. |
| Manufacturer Address | YAD HARUZIM ST. 29 NETANYA, 4250529 IS 4250529 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-27 |