FDA Adverse Event
Malfunction
Summary report: N
MAQUET CARDIOPULMONARY AG
MDR report key: 3823773
·
Received February 20, 2014
Report
- Report Number
- 8010762-2014-00062
- Event Type
- Malfunction
- Date Received
- February 20, 2014
- Date of Event
- January 20, 2014
- Report Date
- January 21, 2014
- Manufacturer
- MAQUET CARDIOPULMONARY AG
- Product Code
- DTQ
- PMA / PMN Number
- K943803
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). A SERVICE TECH WAS ABLE TO REPRODUCE THE ERROR. A BLOWN FUSE WAS FOUND AND REPLACED ON THE MASTER PANEL BOARD. THE UNIT WAS RETURNED TO SERVICE. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED IF FURTHER INFO BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CUSTOMER HAD SET UP THE HEART LUNG MACHINE WITH ALL THE TUBING, PREPARING FOR A CASE. AT SWITCH ON, THE CONTROL PANEL DID NOT DISPLAY ANY NUMBERS, ONLY STARS APPEARED WITH NO RESPONSE FROM THE BUTTONS. NO REPORTED PT EFFECT. INTERNAL REF: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 106556 | MAQUET CARDIOPULMONARY AG | HL 20 CONSOLE BASE | DTQ | MAQUET CARDIOPULMONARY AG | NI | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |