FDA Adverse Event
Malfunction
Summary report: N
UNI-VENT MODEL 731
MDR report key: 4910178
·
Received July 6, 2015
Report
- Report Number
- 2242630-2015-00027
- Event Type
- Malfunction
- Date Received
- July 6, 2015
- Report Date
- June 15, 2015
- Manufacturer
- IMPACT PRODUCTS
- Product Code
- CBK
- PMA / PMN Number
- K111473
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A FOLLOW-UP REPORT WHEN OUR INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING THE DEVICE DISPLAYED AN "INTERNAL COMMUNICATION FAILURE-1474" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 434459 | UNI-VENT MODEL 731 | VENTILATOR | CBK | IMPACT PRODUCTS | 800-EMVP-04 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |