FDA Adverse Event
Malfunction
Summary report: N
UNI-VENT MODEL 754
MDR report key: 4922550
·
Received July 13, 2015
Report
- Report Number
- 2242630-2015-00021
- Event Type
- Malfunction
- Date Received
- July 13, 2015
- Report Date
- June 23, 2015
- Manufacturer
- IMPACT INSTRUMENTATION, INC.
- Product Code
- CBK
- PMA / PMN Number
- K870861
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORP. AND THE CUSTOMER'S REPORT WAS NOT REPLICATED OR CONFIRMED. THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING, WHICH INCLUDED ENVIRONMENTAL AND FUNCTIONAL TESTING WITHOUT DUPLICATING THE MALFUNCTION. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. NO TREND IS ASSOCIATED WITH REPORTS OF THIS TYPE.
Additional Manufacturer Narrative · 1
ZOLL MED.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, THE DEVICE DISPLAYED A "COMPRESSOR ERROR" MESSAGE. IT IS NOT KNOWN WHICH COMPRESSOR ERROR WAS DISPLAYED. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 453344 | UNI-VENT MODEL 754 | CBK | IMPACT INSTRUMENTATION, INC. | 800-0754-10 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |