MAUDE Adverse Event Report: OMRON HEALTHCARE CO., LTD 7 SERIES CONNECTED UPPER ARM BLOOD PRESSURE MONITOR

Model Number	BP7350
Medical Device Problem Codes	Melted (1385); Smoking (1585); Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A root cause has not been determined.It has not been confirmed if the device caused or contributed to the reported incident; however, due to the customer reporting the unit smoking and the screen melting this medwatch is being filed.A postage label has been sent for retrieval of the home unit for inspection.The consumer was offered and accepted a replacement unit.
Event or Problem Description
The contact person called on behalf of the user who experienced the event.They stated their partner had multiple physical illnesses and needed an automatic blood pressure monitor for frequent readings.The machine was purchased from a nearby walgreens.They stated the monitor lasted less than a month.During the event, the user tried to take a blood pressure reading and the monitor started smoking and sparking.The user's father unplugged the machine from the user's arm and took the batteries out of the monitor.It had burn damage and other various burn marks on the machine.A few attempts were made after the initial call to get in contact with the consumer and get additional information.The consumer responded on (b)(6) 2024.They stated that the user was 24 years old.They had the unit for 2 weeks and the unit is used 4 times a day when user would take her medications.The event occurred on 3/7/2024.There was only one person who used the monitor.When taking a reading, the user would sit at the kitchen table with the monitor placed flat on the table.She used her left arm.Her arm circumference was 14 inches.The cuff was snug on the arm and two fingers can be wedged under it when it is applied.Her average blood pressure is 100-120/72.Her last reading in a doctor's office was 104/68.The unit would inflate up to 150 before deflating.The user and her father witnessed the overheating.They stated the machine began to smoke and spark.The user's father immediately unplugged the cuff from the machine and removed the batteries from the monitor.The screen then began to melt.There were no other issues that they were aware of.There was no property or personal damage.The unit operated on batteries not the power cord.The last time the unit was used before the event was 4 hours prior.They were not aware of any other variables regarding the overheating.They requested a replacement unit be sent.
Additional Manufacturer Narrative
After initial report was submitted, the consumer returned the unit back to importer for evaluation.The importer evaluated the returned unit and it failed evaluation due to visual damage.Then, the returned unit was sent to device manufacturer for further testing.Here is the summary of the manufacturer device investigation: the investigation determined that the problem was not caused by the bpm but may be caused by electromagnetic energy from outside the bpm.When the battery short-circuits, the available power 12.5w and it is within 15w, so it is classified in the power sourse circuit ps1 meaning there is limited power and not considered to contain enough energy to result in temperatures sufficient to ignite materials.Since there is not enough power in the unit to cause a spark, an external power source would be required to provide enough energy to produce a spark.The manufacturer reviewed the qa test data, post market data/complaint history for similar issues.No issue/problem was noted during data reviewed by the manufacturer.No issue or no increasing trend was noted for complaint data review.The risk analysis docement was reviewed, and it was determined that no update to risk management documents is required.Since the bpm was determined not to be the cause of the issue, further investigation and correction is not necessary.Importer report #: (b)(4).

• Brand Name: 7 SERIES CONNECTED UPPER ARM BLOOD PRESSURE MONITOR
• Common Device Name: BLOOD PRESSURE MONITOR
• Manufacturer (Section D): OMRON HEALTHCARE CO., LTD; 53 kunotsubo; terado-cho; muko-cuty, kyoto 61700 02; JA 6170002
• Manufacturer (Section G): OMRON HEALTHCARE CO., LTD; 53 kunotsubo; terado-cho; muko-city, kyoto 61700 02; JA 6170002
• Manufacturer Contact: tomoji zukawa ; 53 kunotsubo; terado-cho; muko-city, kyoto 61700-02 ; JA 6170002
• MDR Report Key: 18946960
• Report Number: 8030245-2024-00001
• Device Sequence Number: 20595725
• Product Code: DXN
• UDI-Device Identifier: 00073796267353
• UDI-Public: (01)00073796267353
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K133383
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: BP7350
• Device Catalogue Number: BP7350
• Device Lot Number: 202306V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 24 YR
• Patient Sex: Female