MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-14 for INVOS PATIENT MONITORING PMPAMP71 manufactured by Jabil Circuit (shanghai) Ltd.
[139046717]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[139046718]
According to the reporter, during use, the devices had reading issue. It was stated that the monitor showed low baseline and erratic rso2 reading fluctuating by 40-50% from baseline unilaterally and on both sides. It was stated that first baselines were 20 and 24. Sensors were removed and new ones applied resulting in baselines of 28 and 30. Baselines reading were set on an awake patient receiving 6 lpm of oxygen. It was reported that there was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2936999-2019-00187 |
| MDR Report Key | 8422609 |
| Date Received | 2019-03-14 |
| Date of Report | 2019-03-14 |
| Date of Event | 2019-02-19 |
| Date Mfgr Received | 2019-02-19 |
| Date Added to Maude | 2019-03-14 |
| 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 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 | INVOS PATIENT MONITORING |
| Product Code | QEM |
| Date Received | 2019-03-14 |
| Model Number | PMPAMP71 |
| Catalog Number | PMPAMP71 |
| 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 | 2019-03-14 |