MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-31 for ROOT RDS-7A manufactured by Masimo Corporation.
[177188839]
When performing vital sign checks using the masimo vital sign machine the blood pressure reading will not read properly. The blood pressure pumps up and then releases and this happens a number of times before it finally says "weak signal check cuff. " we have reported this to bio med and they have assessed the machine with no resolution. There are a number of masimo vital sign machines that have this problem. Masimo evaluated equipment with our clinical engineer. Findings copied below: "the issue seems to be that on 1 of the masimo machines, the bp hose connector is a bit loose so air may be slipping out when taking a reading. This may happen if the machine is being pulled by the bp hose/ cable instead of using the handle. The troubleshooting step for this would be to check that the connector is properly fitted and all the way at the end. If the issue persists the bp hose would need to be changed out entirely. Massimo rep was able to train a few of the nurses on the floor on proper handling of the machine and how to troubleshoot and resolve this issue. They will also be providing us with spare bp hoses for replacement when needed. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9652608 |
| MDR Report Key | 9652608 |
| Date Received | 2020-01-31 |
| Date of Report | 2020-01-15 |
| Date of Event | 2020-01-03 |
| Report Date | 2020-01-15 |
| Date Reported to FDA | 2020-01-15 |
| Date Reported to Mfgr | 2020-01-31 |
| Date Added to Maude | 2020-01-31 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROOT |
| Generic Name | MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS) |
| Product Code | MWI |
| Date Received | 2020-01-31 |
| Model Number | RDS-7A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MASIMO CORPORATION |
| Manufacturer Address | 52 DISCOVERY IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-31 |