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 2018-05-21 for BIS 186-0106 manufactured by Celestica Electronics S Pte Ltd.
[108858766]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[108858767]
According to the reporter, during the procedure, the device had low reading because it had a value of 70 in the beginning of the procedure without medication. The user concluded that the reading was incorrect because the patient was awake. The customer reported that there was no patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2936999-2018-00356 |
| MDR Report Key | 7531370 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-05-21 |
| Date of Report | 2019-02-19 |
| Date of Event | 2018-05-10 |
| Date Mfgr Received | 2019-01-22 |
| Device Manufacturer Date | 2017-07-16 |
| Date Added to Maude | 2018-05-21 |
| 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 | 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 | 2018-05-21 |
| Returned To Mfg | 2019-01-12 |
| Model Number | 186-0106 |
| Catalog Number | 186-0106 |
| Lot Number | 0716171L |
| Device Expiration Date | 2019-01-16 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2018-05-21 |