MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-03-31 for CARESTATION 650 A1 manufactured by Ge Medical Systems (china) Co., Ltd (wuxi).
[186174754]
A ge healthcare service representative performed a checkout of the system and confirmed the reported issue. Replaced both o2 and n2o sprockets and link chain to resolve the reported issue. No report of patient involvement. The initial reporter is located outside the u. S. , and therefore this information is not provided due to country privacy laws. Unique identifier: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[186174755]
The hospital reported a malfunction of the link 25 system causing a hypoxic mix in the patient circuit. There was no report of patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710602-2020-00117 |
| MDR Report Key | 9905282 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-05 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2017-11-27 |
| Date Added to Maude | 2020-03-31 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JOHN SZALINSKI |
| Manufacturer Street | 3000 N GRANDVIEW BLVD. |
| Manufacturer City | WAUKESHA WI |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARESTATION 650 A1 |
| Generic Name | ANESTHESIA GAS MACHINE |
| Product Code | BSZ |
| Date Received | 2020-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI) |
| Manufacturer Address | NO. 19 CHANGJIANG ROAD NATIONAL HI-TECH DEV. ZONE WUXI 214028 CH 214028 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |