MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2018-08-29 for BIS 186-0106 manufactured by Celestica Electronics S Pte Ltd.
[118756848]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[118756849]
According to the reporter, the unit had low readings. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2936999-2018-00541 |
| MDR Report Key | 7828100 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-08-29 |
| Date of Report | 2018-08-29 |
| Date of Event | 2018-08-03 |
| Date Mfgr Received | 2018-08-13 |
| Device Manufacturer Date | 2018-01-15 |
| Date Added to Maude | 2018-08-29 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | AVI KLUGER |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 3035306582 |
| Manufacturer G1 | CELESTICA ELECTRONICS S PTE LTD |
| Manufacturer Street | NO. 6 SERANGOON NORTH AVENUE 5 |
| Manufacturer City | SINGAPORE 554910 |
| Manufacturer Country | SG |
| Manufacturer Postal Code | 554910 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIS |
| Generic Name | ELECTRODE, CUTANEOUS |
| Product Code | GXY |
| Date Received | 2018-08-29 |
| Returned To Mfg | 2019-05-02 |
| Model Number | 186-0106 |
| Catalog Number | 186-0106 |
| Lot Number | 0115181K |
| Device Expiration Date | 2019-07-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CELESTICA ELECTRONICS S PTE LTD |
| Manufacturer Address | NO. 6 SERANGOON NORTH AVENUE 5 SINGAPORE 554910 SG 554910 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-29 |