FDA Adverse Event
Injury
Summary report: N
ROTAFLOW ENGLISH/US US-PLUG ICU
MDR report key: 4791736
·
Received May 21, 2015
Report
- Report Number
- 8010762-2015-00446
- Event Type
- Injury
- Date Received
- May 21, 2015
- Manufacturer
- MAQUET CARDIOPULMONARY AG
- Product Code
- DTQ
- PMA / PMN Number
- K991864
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). MAQUET CARDIOPULMONARY PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT. THE DEVICE WAS INVESTIGATED BY A MAQUET SERVICE TECHNICIAN. UPON ARRIVAL THE BATTERY WAS TESTED. THE UNIT POWERED ON WITH THE BATTERY READING 23.4 VOLTS. TESTED AT 2500 RMP/4LPM ON BATTERY. UNIT RAN FOR 108 MINUTES BEFORE LOW BATTERY ALARM. PLUGGED IN AND VERIFIED UNIT WAS CHARGING. UNABLE TO DUPLICATE THE SHORT RUN TIME. PERFORMED FUNCTIONAL TESTS. VERIFIED THE UNIT WAS CALIBRATED TO FACTORY SPECIFICATIONS. SAFETY INSPECTED. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. REFERENCE EXEMPTION # (B)(4).
Description of Event or Problem · 1
(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 333347 | ROTAFLOW ENGLISH/US US-PLUG ICU | DTQ | MAQUET CARDIOPULMONARY AG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |