MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2020-01-22 for MINDRAY MPM MULTI PARAMETER MODULE FMMR1000 manufactured by Shenzhen Mindray Bio-meidcal Electronics Co., Ltd.
[181554404]
The complaint device was returned for evaluation. Visual inspection found no anomalies. Device evaluation identified an spo2 malfunction confirming the reported event. The spo2 connector was refurbished. The front and rear cases were inspected. Diagnostics were ran and all pcbs were tested. The case was checked for damage. The root cause for the reported issue was determined to be a bad solder joint. This type of reported event will continue to be monitored. It should be noted that this is being filed based on retrospective review.
Patient Sequence No: 1, Text Type: N, H10
[181554405]
Reportedly, post repair, the device was still having intermittent spo2 issues. There was no report of patient harm or patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007409280-2020-00011 |
| MDR Report Key | 9616841 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2020-01-22 |
| Date of Report | 2018-07-18 |
| Date Mfgr Received | 2018-07-18 |
| Date Added to Maude | 2020-01-22 |
| 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 | JENNA VARGAS |
| Manufacturer Street | 212 AVENIDA FABRICANTE |
| Manufacturer City | SAN CLEMENTE CA 92672 |
| Manufacturer Country | US |
| Manufacturer Postal | 92672 |
| Manufacturer Phone | 8004495328 |
| Manufacturer G1 | AVANTE HEALTH SOLUTIONS |
| Manufacturer Street | 212 AVENIDA FABRICANTE |
| Manufacturer City | SAN CLEMENTE CA 92672 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92672 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MINDRAY MPM MULTI PARAMETER MODULE |
| Generic Name | HYPERVISOR CENTRAL MONITORING SYSTEM |
| Product Code | MSX |
| Date Received | 2020-01-22 |
| Returned To Mfg | 2018-07-23 |
| Model Number | FMMR1000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SHENZHEN MINDRAY BIO-MEIDCAL ELECTRONICS CO., LTD |
| Manufacturer Address | 800 MACARTHUR BLVD. MAHWAH NJ 07430 US 07430 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-22 |