MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-03-04 for GAS MODULE 3 * manufactured by Mindray Ds Usa, Inc.
[4351561]
We have had 4 repairs on this gas module for anesthesia in 4 years, all having to do with the gas module not electronically connecting to the mindray spectrum or 1 monitor. When we return the unit to mindray they do not find any problems and send the unit back. Each time it is returned it works for a period of time and then fails again. ======================manufacturer response for anesthesia co2 monitoring module, mindray gas module 3 (per site reporter). ======================mindray has given the hospital a verbal agreement to provide the hospital with a replacement gas module 3.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3659157 |
| MDR Report Key | 3659157 |
| Date Received | 2014-03-04 |
| Date of Report | 2014-03-04 |
| Date of Event | 2014-02-15 |
| Report Date | 2014-03-04 |
| Date Reported to FDA | 2014-03-04 |
| Date Reported to Mfgr | 2014-03-05 |
| Date Added to Maude | 2014-03-05 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GAS MODULE 3 |
| Generic Name | SPIROMETER, MONITORING |
| Product Code | BZK |
| Date Received | 2014-03-04 |
| Returned To Mfg | 2014-02-28 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | R |
| Device Age | 6 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MINDRAY DS USA, INC |
| Manufacturer Address | 800 MACARTHUR BLVD MAHWAH NJ 07430 US 07430 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-04 |