MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-23 for UNKINVOS UNSPECIFIED INVOS PRODUCT manufactured by Jabil Circuit (shanghai) Ltd.
[142865353]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[142865354]
According to the reporter, the nurse noted that there was slight pressure injury from the device.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2936999-2019-00305 |
MDR Report Key | 8542144 |
Date Received | 2019-04-23 |
Date of Report | 2019-04-23 |
Date Mfgr Received | 2019-04-04 |
Date Added to Maude | 2019-04-23 |
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 | 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,20 200233 |
Manufacturer Country | CN |
Manufacturer Postal Code | 200233 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 0 |
Brand Name | UNKINVOS |
Product Code | QEM |
Date Received | 2019-04-23 |
Model Number | UNSPECIFIED INVOS PRODUCT |
Catalog Number | UNSPECIFIED INVOS PRODUCT |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | JABIL CIRCUIT (SHANGHAI) LTD |
Manufacturer Address | NO 600 TIAN LIN ROAD SHANGHAI,20 200233 CN 200233 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2019-04-23 |