FDA Adverse Event
Malfunction
Summary report: N
I-STAT DOWNLOADER, NETWORK
MDR report key: 6646195
·
Received June 16, 2017
Report
- Report Number
- 2245578-2017-00025
- Event Type
- Malfunction
- Date Received
- June 16, 2017
- Date of Event
- June 6, 2017
- Report Date
- September 15, 2017
- Manufacturer
- ABBOTT POINT OF CARE
- Product Code
- RHA
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
APOC INCIDENT # (B)(4). THE INVESTIGATION WAS COMPLETED ON 09/08/2017. THE FAILURE WAS DUE TO A FAILED TRANSISTOR Q1 ON THE FAST CHARGE PCBA OF THE DRN.
Additional Manufacturer Narrative · 1
APOC INCIDENT # (B)(4). APOC LABELING WILL BE EVALUATED DURING THE INVESTIGATION AS PERTAINING TO THE EVENT.
Description of Event or Problem · 1
NA.
Description of Event or Problem · 1
ON (B)(6) 2017, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER WHO REPORTED VISUAL SMOKE COMING FROM NETWORK DOWNLOADER (DRN-19611). THE DEVICE WAS TAKEN OUT OF SERVICE, REPLACED AT NO CHARGE AND RETURNING FOR INVESTIGATION. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 429837 | I-STAT DOWNLOADER, NETWORK | DOWNLOADER, NETWORK | RHA | ABBOTT POINT OF CARE | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |