BLINQ PEDIATRIC VISION SCANNER
Received Jan 3, 2024 · Event occurred Oct 18, 2022
Report 3014522421-2022-00009 · MDR key 18433807
Device
Product problems
- Premature Discharge of Battery
- Premature Discharge of Battery
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT DEVICE WILL NOT CHARGE.
Additional Manufacturer Narrative
THE INABILITY OF THE DEVICE TO CHARGE HAS BEEN ATTRIBUTED TO THE BATTERY PACK. THE BATTERY PACK IS AN OFF-THE-SHELF BATTERY PACK THAT IS DESIGNED BY THE BATTERY-PACK SUPPLIER TO HAVE UNDER-VOLTAGE PROTECTION, WHICH WOULD PREVENT A BATTERY PACK HAVING LESS THAN 2.5V/CELL FROM BEING CHARGED. THE SUPPLIER OF THE BATTERY PACK HAD DISABLED THIS FEATURE WITHOUT NOTIFYING CUSTOMERS. THE RESULT MAY LEAD TO A BATTERY PACK TO VENT, WHICH COULD LEAD TO A FIRE, IF THE BATTERY PACK WITH LESS THAN 2.5V/CELL IS ATTEMPTED TO BE CHARGED. A REMOVAL UNDER 21 CFR PART 810 HAS BEEN INITIATED. AN APPROPRIATE CONCLUSION CODE IS NOT AVAILABLE. CAUSE IS ATTRIBUTED TO SUPPLIER ERROR FOR OFF-THE-SHELF COMPONENT. REF: MFR FILE (B)(4). THIS REPORT IS SUBMITTED LATE. THIS IS THE COMPANY'S FIRST ELECTRONIC MDR SUBMISSION AND IS LATE DUE TO DELAYS AND ISSUES ENCOUNTERED DURING THE SIGN-UP PROCESS.
Remedial action
- Recall