FDA Adverse Event
Malfunction
Summary report: N
MARTEL PRINTER FOR THE I-STAT 1 ANALYZER
MDR report key: 2192523
·
Received June 30, 2011
Report
- Report Number
- 2245578-2011-00105
- Event Type
- Malfunction
- Date Received
- June 30, 2011
- Date of Event
- June 29, 2011
- Report Date
- June 30, 2011
- Manufacturer
- MARTEL INSTRUMENTS
- Product Code
- JPA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ON (B)(6) 2011, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER WHO REPORTED THAT A MARTEL PRINTER BECOMES HOT TO TOUCH AND BURNS PAPER. BASED ON THE INFO AVAILABLE AT THE TIME , THERE WERE NO INJURIES ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MARTEL PRINTER FOR THE I-STAT 1 ANALYZER | MARTEL PRINTER | JPA | MARTEL INSTRUMENTS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |