BLINQ PEDIATRIC VISION SCANNER
Received Jan 3, 2024 · Event occurred Aug 14, 2022
Report 3014522421-2022-00008 · MDR key 18433812
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
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 CF-47 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.
Description of Event or Problem
THE CUSTOMER REPORTED THAT AFTER 6 MONTHS IN STORAGE THE DEVICE WAS TURNED ON AND A BATTERY ISSUE WAS SHOWN.
Remedial action
- Recall