FDA Adverse Event
Malfunction
Summary report: N
CARESCAPE R860
MDR report key: 16429515
·
Received February 23, 2023
Report
- Report Number
- 2112667-2023-00894
- Event Type
- Malfunction
- Date Received
- February 23, 2023
- Date of Event
- June 22, 2022
- Report Date
- February 23, 2023
- Manufacturer
- DATEX-OHMEDA, INC.
- Product Code
- CBK
- PMA / PMN Number
- K142679
- Removal / Correction Number
- Z-1226-2022, Z-1227-2022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
UDI : (B)(4). LEGAL MANUFACTURER: HCS MADISON - 3030 OHMEDA DR, USA MADISON, WI 53718.
Description of Event or Problem · 0
AS A RESULT OF AN INSPECTION THAT WAS COMPLETED AS PART OF CORRECTION AND REMOVAL INITIATED BY GE HEALTHCARE (GEHC) ON 21-APR-2022 (RECALL NO. Z-1226-2022, Z-1227-2022), THIS UNIT WAS IDENTIFIED AS HAVING A BATTERY PERFORMANCE THAT INDICATES IT MAY BE IMPACTED BY THE ISSUE DESCRIBED IN THE RECALL NO. Z-1226-2022, Z-1227-2022. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 473982 | CARESCAPE R860 | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | DATEX-OHMEDA, INC. | 1506-8600-000-65985 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |