MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-26 for GAS MODULE 3 0998-00-1900-01 manufactured by Shenzhen Mindray Bio-medical Electronics Co., Ltd.
[185142093]
The user facility requested an evaluation of the equipment; no malfunction of the equipment was claimed. The results of the evaluation determined the gas module required n2o calibration only.
Patient Sequence No: 1, Text Type: N, H10
[185142094]
It was reported that a patient monitored on a passport 2 monitor and gas module was having surgery and one minute into the procedure the patient's heart stopped; the patient later expired.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009156722-2020-00006 |
| MDR Report Key | 9886524 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-26 |
| Date of Report | 2020-02-28 |
| Date of Event | 2020-02-21 |
| Date Mfgr Received | 2020-02-28 |
| Date Added to Maude | 2020-03-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 |
| Manufacturer Contact | MS SERENA CHEN |
| Manufacturer Street | 1203 NANHUAN AVENUE GUANGMING DISTRICT |
| Manufacturer City | SHENZHEN, SHENZHEN 518106 |
| Manufacturer Country | CH |
| Manufacturer Postal | 518106 |
| Manufacturer G1 | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
| Manufacturer Street | BUILDINGS 9-13 BAIWANGXIN HIGH-TECH INDUSTRIAL PARK |
| Manufacturer City | BAIMANG, XILI TOWN, NANSHAN, SHENZEN 518108 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 518108 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GAS MODULE 3 |
| Generic Name | GAS MODULE |
| Product Code | BZK |
| Date Received | 2020-03-26 |
| Catalog Number | 0998-00-1900-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
| Manufacturer Address | BUILDINGS 9-13 BAIWANGXIN HIGH-TECH INDUSTRIAL PARK BAIMANG, XILI TOWN, NANSHAN, SHENZEN 518108 CH 518108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-03-26 |