MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2018-11-05 for BIS UNSPECIFIED BIS PRODUCT manufactured by Celestica Electronics S Pte Ltd.
[126086902]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[126086903]
According to the reporter, post operative of vascular assist device (vad) implantation, the devices were used for monitoring and had an unknown failure. The customer indicated that on the 5th postoperative day of weaning from a mechanical ventilation, the patient developed pulmonary congestion with respiratory distress, decreased arterial oxygen saturation, and elevated pulmonary artery pressure (pap).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2936999-2018-00671 |
| MDR Report Key | 8037406 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2018-11-05 |
| Date of Report | 2018-11-05 |
| Date Mfgr Received | 2018-10-09 |
| Date Added to Maude | 2018-11-05 |
| 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 | 5920 LONGBOW DRIVE |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| 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 | 2018-11-05 |
| Model Number | UNSPECIFIED BIS PRODUCT |
| Catalog Number | UNSPECIFIED BIS PRODUCT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 1. Other | 2018-11-05 |