FDA Adverse Event
Malfunction
Summary report: N
MODEL 754
MDR report key: 4868833
·
Received June 22, 2015
Report
- Report Number
- 2242630-2015-00014
- Event Type
- Malfunction
- Date Received
- June 22, 2015
- Report Date
- June 2, 2015
- Manufacturer
- IMPACT PRODUCTS
- Product Code
- CBK
- PMA / PMN Number
- K870861
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORP 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 A ROUTINE SHIFT CHECK BY A CLINICIAN, UPON POWER UP THE DEVICE DISPLAYED AN UNK CRITICAL ERROR MAINTENANCE MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 402712 | MODEL 754 | VENTILATOR | CBK | IMPACT PRODUCTS | 800-0754-02 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |