PROVITA
Received Oct 23, 2025 · Event occurred Dec 10, 2024
Report 3002732397-2025-00001 · MDR key 23367284
Device
Generic name
Mobile Surgical Light
Manufacturer
Provita Medical Gmbh & Co. KgModel number
MRT LAMPCatalog number
350826
Lot number
23-2575
Product problems
- Fail-Safe Did Not Operate
- Fail-Safe Did Not Operate
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
CORRECTIONS MADE: YEAR, RESPONSE TO FDA REQUEST; SUPPLEMENT 1.
Description of Event or Problem
THIS IS A SURGICAL LAMP FOR USE IN MRI ENVIRONMENTS. IT IS BATTERY OPERATED, EMPLOYING A LITHIUM ION RECHARGEABLE BATTERY. THE BATTERY IS UL LISTED. WE HAVE BECOME AWARE OF A BATTERY FAILURE, DEVICE NAME: SERIES 1 MOBILE LED UL/MRI-LAMP WITH BATTERY. SYMPTOM: BATTERY OVERHEATED. DURING CHARGING PROCESS OF THE BATTERY PACK THE BATTERY OVERHEATED AND DAMAGED THE BATTERY HOUSING. NO PERSONS HAVE BEEN HURT.
Description of Event or Problem
THIS IS A SURGICAL LAMP FOR USE IN MRI ENVIRONMENTS. IT IS BATTERY OPERATED, EMPLOYING A LITHIUM ION RECHARGEABLE BATTERY. THE BATTERY IS UL LISTED. WE HAVE BECOME AWARE OF A BATTERY FAILURE, DEVICE NAME: SERIES 1 MOBILE LED UL/MRI-LAMP WITH BATTERY. SYMPTOM: BATTERY OVERHEATED. DURING CHARGING PROCESS OF THE BATTERY PACK THE BATTERY OVERHEATED AND DAMAGED THE BATTERY HOUSING. NO PERSONS HAVE BEEN HURT.
Remedial action
- Replace