FDA Adverse Event Injury Summary report: N

NONIN WRISTOX2 PULSE OXIMETER

MDR report key: 9647597 · Received January 30, 2020

Report

Report Number: 3007389703-2020-00001
Event Type: Injury
Date Received: January 30, 2020
Date of Event: January 17, 2020
Report Date: January 31, 2020
Manufacturer: NONIN MEDICAL INC.
Product Code: DQA
PMA / PMN Number: K102350
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

NOX MEDICAL IS A REPACKAGER OF THE NONIN 3150 PULSE OXIMETER, THAT IS INCLUDED IN THE NOX T3 SYSTEM. THE LEGAL MANUFACTURER OF THE FINISHED DEVICE IS NONIN MEDICAL INC. THAT HAS BEEN NOTIFIED OF THE REPORTED EVENT. THE SUSPECTED DEVICE WILL BE SENT DIRECTLY FROM (B)(4) (THE IMPORTER AND DISTRIBUTOR) TO NONIN MEDICAL (THE FINISHED DEVICE LEGAL MANUFACTURER) FOR FURTHER EVALUATION. NOX MEDICAL HAS EVALUATED THE INFORMATION RELATED TO THIS REPORTED EVENT AND CAME TO THE CONCLUSION THAT THE INCIDENT IS NOT RELATED TO THE REPACKAGING OF THE NONIN 3150 PULSE OXIMETER PERFORMED BY NOX MEDICAL. ANY FURTHER REPORTS WILL COME FROM NONIN MEDICAL INC. THE FINISHED DEVICE LEGAL MANUFACTURER.

Description of Event or Problem · 1

PATIENT BEING BURNED ON THE WRIST. THE PATIENT DESCRIBED AROUND MIDNIGHT WAKING UP FEELING A BURNING SENSATION ON HER WRIST WHERE THE NONIN WRIST OX WAS WORN. SHE TOOK THE WRIST OX DEVICE OFF AND NOTICED THE BATTERY DOOR HAD SLID 1/4 OF THE WAY OPEN. SHE TOOK THE BATTERY OUT, THEN PLACED IT BACK IN AND SLID THE DOOR CLOSED AND RESUMED THE STUDY. (B)(6) DESCRIBES THE PATIENT WRIST AREA WITH A BLISTER, THAT WOULD EVENTUALLY OPEN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
108868	NONIN WRISTOX2 PULSE OXIMETER	WRIST-WORN PULSE OXIMETER, PRODUCT CODE	DQA	NONIN MEDICAL INC.	MODEL 3150

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other