MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-26 for CARESCAPE R860 manufactured by Datex-ohmeda, Inc..
[131587460]
A ge healthcare service representative replaced the main ventilator housing to resolve the reported issue. No report of patient involvement. (b)(4). The initial reporter is located outside the u. S. , and therefore this information is not provided due to country privacy laws.
Patient Sequence No: 1, Text Type: N, H10
[131587461]
A ge healthcare service representative reported that the trolley locking part in the housing section was broken. There was no report of patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2112667-2018-02552 |
| MDR Report Key | 8197045 |
| Date Received | 2018-12-26 |
| Date of Report | 2018-12-26 |
| Date of Event | 2018-11-27 |
| Date Mfgr Received | 2018-11-27 |
| Device Manufacturer Date | 2018-07-30 |
| Date Added to Maude | 2018-12-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 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 | 0 |
| Brand Name | CARESCAPE R860 |
| Generic Name | VENTILATOR, CONTINUOUS, FACILITY USE |
| Product Code | CBL |
| Date Received | 2018-12-26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DATEX-OHMEDA, INC. |
| Manufacturer Address | 3030 OHMEDA DR, MADISON, WI 53718 US 53718 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-26 |