FDA Adverse Event
Malfunction
Summary report: N
MODEL EMV+ VENT, ARMY, COMMERCIAL
MDR report key: 23131461
·
Received September 24, 2025
Report
- Report Number
- 1220908-2025-03510
- Event Type
- Malfunction
- Date Received
- September 24, 2025
- Date of Event
- September 3, 2025
- Report Date
- September 3, 2025
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- CBK
- UDI-DI
- 00847946023416
- PMA / PMN Number
- K162832
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A SUPPLEMENTAL REPORT WHEN OUR INVESTIGATION IS COMPLETED.
Additional Manufacturer Narrative · 0
THE DEVICE WAS EVALUATED BY ZOLL MEDICAL CORPORATION. THE CUSTOMER'S REPORT WAS DUPLICATED AND ATTRIBUTED TO THE MASIMO PRINTED CIRCUIT BOARD. THE PRINTED CIRCUIT BOARD WAS REPLACED TO RESOLVE THE REPORT. THE BOARD WAS SCRAPPED AFTER TESTING. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.
Description of Event or Problem · 0
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED A"SELF-CHECK FAILURE" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1613931 | MODEL EMV+ VENT, ARMY, COMMERCIAL | VENTILATOR | CBK | ZOLL MEDICAL CORPORATION | 799-EMVP-01-01 | NA | 00847946023416 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |