FDA Adverse Event
Injury
Summary report: N
MAQUET CARDIOPULMONARY AG
MDR report key: 3763278
·
Received April 4, 2014
Report
- Report Number
- 8010762-2014-00176
- Event Type
- Injury
- Date Received
- April 4, 2014
- Date of Event
- February 4, 2014
- Report Date
- February 5, 2014
- Manufacturer
- MAQUET CARDIOPULMONARY AG
- Product Code
- DTQ
- PMA / PMN Number
- K943803
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MY
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). MAQUET (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND CORRECTIVE ACTIONS FOR THE DEVICE DESCRIBED IN THIS REPORT. A MAQUET FIELD SERVICE ENGINEER INVESTIGATED THE DEVICE AND WAS NOT ABLE TO REPRODUCE THE ERROR CODE. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHILE IN USE THE ARTERIAL MASTER PUMP ON THE HL20 HAD THE ERROR CODE 17 (UNEXPECTED ERROR). THE CUSTOMER SWITCHED OFF THE PUMP AND BEGAN HAND-CRANKING. AFTER TWO MINUTES THE PUMP WAS SWITCHED BACK ON AND FUNCTIONED CORRECTLY. INTERNAL REF.# 705002543.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 203588 | MAQUET CARDIOPULMONARY AG | HL 20 CONSOLE BASE | DTQ | MAQUET CARDIOPULMONARY AG | NI | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Other| R |