EREADER+ DRUG SCREENING INSTRUMENT
Report
- Report Number
- 2032598-2023-00001
- Event Type
- Malfunction
- Date Received
- May 2, 2023
- Date of Event
- April 3, 2023
- Report Date
- November 16, 2023
- Manufacturer
- AMEDITECH, INC.
- Product Code
- JJQ
- UDI-DI
- 00816565021530
- PMA / PMN Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INVESTIGATION OF THIS EVENT IS IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
THE INSTRUMENT WAS RETURNED FOR INVESTIGATION. THE UNIT AND ITS POWER SUPPLY PASSED ELECTRICAL SAFETY TESTING, INDICATING THAT NO HAZARDOUS VOLTAGES WERE PRESENT. A REVIEW OF THE INCOMING INSPECTION RECORD FOR THE RETURNED INSTRUMENT ENCOUNTERED NO ISSUES. A REVIEW OF THE INSTRUMENT'S OPERATOR GUIDE FOUND NO EVIDENCE OF USER ERROR OR MISUSE. BASED ON THE COMPLETED INVESTIGATION ACTIVITIES AND AVAILABLE INFORMATION, AN ASSIGNABLE CAUSE COULD NOT BE DETERMINED.
IT WAS REPORTED THAT THE EREADER+ INSTRUMENT SHOCKED A CLINICIAN WHEN THEY WERE ADJUSTING THE INSTRUMENT'S CONNECTION TO THE ADJACENT COMPUTER. REPORTEDLY, THE SHOCK OCCURRED WHEN TOUCHING THE USB CORD THAT CONNECTED THE INSTRUMENT TO THE BACK OF THE COMPUTER. THE CLINICIAN DID NOT WANT TO TROUBLESHOOT THE ISSUE FURTHER, DUE TO FEAR OF GETTING SHOCKED AGAIN. NO INJURY AND/OR MEDICAL INTERVENTION WAS NOTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2321164 | EREADER+ DRUG SCREENING INSTRUMENT | EREADER+ | JJQ | AMEDITECH, INC. | 55161 | N/A | 00816565021530 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |