DUO BATTERY HOLSTER - QUANTITY ONE
Received Dec 10, 2020 · Event occurred Nov 19, 2020
Report 2523190-2020-00152 · MDR key 10983312
Device
Generic name
Pfm05
Catalog number
90621
Product problems
- Overheating of Device
- Ambient Temperature Problem
- Overheating of Device
- Ambient Temperature Problem
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem
THIS IS 3 OF 3 REPORTS WHICH ARE LINKED TO MFG REPORT NUMBERS: 2523190-2020-00150; 2523190-2020-00151. A FACILITY REPORTED THAT WHILE THE SURGEON WAS USING THE HEADLIGHT DURING A SPINAL CASE, THE LITHIUM ION BATTERY BEGAN TO GET HOT ON HIS HIP. IT WAS TAKEN OFF AND THERE WAS LIQUID COMING FROM THE BATTERY. ADDITIONALLY, THE KNOB OF THE DUO BATTERY HOLSTER WAS ALSO COMING OFF AND WAS BEING HELD ON WITH TAPE. THERE WAS NO PATIENT INJURY AND THE SURGEON'S CONDITION WAS FINE. THERE WAS A DELAY IN SURGERY OF 1 TO 3 MINUTES TO CHANGE THE BATTERIES.
Additional Manufacturer Narrative
UNIQUE DEVICE IDENTIFIER (UDI #): (B)(4). DEVICE HISTORY RECORD (DHR) - DHR SHOWS NO ABNORMALITIES RELATED TO THE REPORTED ISSUE. THE RETURNED 90621 DUO BATTERY HOLSTER WAS IN USED CONDITION WITH THE CONTROL KNOB BROKEN OFF DUE TO PHYSICAL DAMAGE. THE REPORTED COMPLAINT IS CONFIRMED. NO FURTHER INVESTIGATION REQUIRED BASED ON THE ACCEPTABILITY OF RISK AND NO ADVERSE TRENDS IDENTIFIED. THIS WILL BE MONITORED AND TRENDED GOING FORWARD.