MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-20 for ADULT SENSOR PMSENS71-A INVOS KIT PMSENS71-A-20 manufactured by Jabil Circuit(shanghai) Ltd.
[184262354]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[184262355]
According to the reporter, during service and repair, the device caused skin reaction post application of sensors. There was no patient involvement, device was tested with a service and repair personnel.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2936999-2020-00214 |
| MDR Report Key | 9859451 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-02-28 |
| Date Mfgr Received | 2020-02-28 |
| Date Added to Maude | 2020-03-20 |
| 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 | JABIL CIRCUIT(SHANGHAI) LTD |
| Manufacturer Street | NO 600 TIAN LIN RD |
| Manufacturer City | SHANGHAI 20023 |
| Manufacturer Country | CN |
| Manufacturer Postal Code | 20023 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADULT SENSOR PMSENS71-A INVOS KIT |
| Generic Name | OXIMETER, TISSUE SATURATION |
| Product Code | MUD |
| Date Received | 2020-03-20 |
| Model Number | PMSENS71-A-20 |
| Catalog Number | PMSENS71-A-20 |
| 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 RD SHANGHAI 20023 CN 20023 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-20 |