MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-01-28 for INVOS 5100C-US manufactured by Jabil Circuit (shanghai) Ltd.
[176681236]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[176681237]
According to the reporter, the device gave low readings. There was no reported patient involvement or outcome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2936999-2020-00061 |
| MDR Report Key | 9639136 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-01-28 |
| Date of Report | 2020-01-28 |
| Date of Event | 2020-01-02 |
| Date Mfgr Received | 2020-01-13 |
| Date Added to Maude | 2020-01-28 |
| 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 | BIOMEDICAL ENGINEER |
| 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 | JABIL CIRCUIT (SHANGHAI) LTD |
| Manufacturer Street | NO 600 TIAN LIN ROAD |
| Manufacturer City | SHANGHAI,020 200233 |
| Manufacturer Country | CN |
| Manufacturer Postal Code | 200233 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INVOS |
| Generic Name | OXIMETER, TISSUE SATURATION |
| Product Code | MUD |
| Date Received | 2020-01-28 |
| Returned To Mfg | 2020-01-17 |
| Model Number | 5100C-US |
| Catalog Number | 5100C-US |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JABIL CIRCUIT (SHANGHAI) LTD |
| Manufacturer Address | NO 600 TIAN LIN ROAD SHANGHAI,020 200233 CN 200233 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-28 |