FDA Adverse Event
Malfunction
Summary report: N
AIRCAST VENAPRO SYSTEM
MDR report key: 9717630
·
Received February 17, 2020
Report
- Report Number
- 3005844491-2020-00013
- Event Type
- Malfunction
- Date Received
- February 17, 2020
- Date of Event
- February 13, 2020
- Report Date
- February 17, 2020
- Manufacturer
- INNOVAMED HEALTH, LLC
- Product Code
- JOW
- UDI-DI
- 00190446273288
- PMA / PMN Number
- K133274
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
OPERATOR OF DEVICE, HEALTH PROFESSIONAL, OCCUPATION: UNKNOWN. NO DEVICE WAS RETURNED FOR EVALUATION. IF THE DEVICE IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF PRODUCT EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE "PUMP GOT HOT AND TURNED OFF LAST NIGHT WHEN IT WAS PLUGGED IN". THERE WAS NO REPORTED PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 179156 | AIRCAST VENAPRO SYSTEM | SLEEVE, LIMB, COMPRESSIBLE | JOW | INNOVAMED HEALTH, LLC | 30M | 00190446273288 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |