MAUDE Adverse Event Report: OMRON HEALTHCARE CO., LTD 5 SERIES CONNECTED UPPER ARM BLOOD PRESSURE MONITOR

Model Number BP7250

Device Problem Inflation Problem (1310)

Patient Problems Loss of Range of Motion (2032); Myalgia (2238); Physical Asymmetry (4573); Swelling/ Edema (4577)

Event Date 09/11/2022

Event Type  Injury  

Manufacturer Narrative

A postage label has been sent for retrieval of the home unit for inspection.A root cause has not been determined, it has not been confirmed if the device casued or contributed to the reported incident, however because the consumer reported her arm was swollen days after using the monitor, and she seeked medical attention for the discomfort and pain so the medwatch is being filed.

Event Description

The consumer stated that, after she purchased the unit, she used the monitor once or twice a week except during the month of may.She stated she hated the unit because it squeezed too tightly to the point her left arm was nearly fainting.She stated it was painful and that her arm felt like it was being wrapped around by a boa constrictor type of snake.She noticed a rhythm of her heart going "lub-dub" coming from her inner arm cuff several seconds before the squeeze was over.She felt relieved when it was done.She had never had any injury to her arms in her life.On (b)(6) 2022, her first measurement was tight as usual so she shut off the unit and checked for its position and snugness.She gave herself a break before taking another measurement.The following morning, she was changing her clothing when she noticed a pain in her left arm between her wrist and elbow.The area was warm to the touch and the muscle was hard like it was pumped up.She iced her arm, but it did not help; there was no improvement.Her arm was still painful and warm and the area was still hard while she was lying in bed.She believed her omron blood pressure monitor was the cause.She stated the unit inflated longer than it should.She did not know how high it inflated.She took her blood pressure while sitting on the edge of her bed or sometimes while lying down.She was the only user and her arm circumference was 11".She stated it did not hurt when the doctor took her blood pressure.On (b)(6) 2022, she followedup with her primary care physician during an appointment.They examined her, and her doctor issued a medical report.They gave her a copy of the report.She was still experiencing pain on (b)(6) 2022.She emailed stating that she did not receive her shipping label to return her unit to the inspection center.She stated she would send the medical report from her primary care provider who examined her injury when she gets her label.She stated her arm was still in pain with limited mobility and there was swelling and a bump.Her doctor stated it would take 2 weeks for the swelling to go away and that she has a muscle injury from her blood pressure monitor.Her doctor advised her to stop using the unit.She was taking ibuprofen daily, but no further testing was done or any other medication was prescribed.She stated she notified the fda due to the injury.A replacement unit will be sent to the consumer.

Manufacturer Narrative

Additional information added to section g6, h2, h3, h6, and h10.The unit was sent to device manufacturer for further testing.Here is the summary of the manufacturer device investigation: the unit was tested and unit was working within specifications.Therefore, the consumer returned product was judged a conforming product.Further investigation in to cause was considered since the consumer had stated the unit hurt the consumer's arm.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.There were 287 measurements and no abnormalities were found in the recorded data.When the returned cuff and sample cuff were respectively connected to the returned unit and measured, there was no difference in tightening or in the measured values.The cuff showed no abnormal shape or difference from a sample cuff.There were many "irregular heartbeat symbols" left in the consumer's measurement record.The instruction manual states the following: "if it continues to appear, we recommend you to consult with and follow the directions of your physician." possible causes of the reported muscle pain and swelling could not be confirmed, but are as follows: 1.Excessively continuous measurement 2.The pressure value increased due to body movement during measurement 3.The cuff didn't fit the customer constitutionally 4.The customer had muscle or blood vessel disease.Following cautions are provided in the instructions manual: -rest for at least 5 minutes before taking a measurement.-remain still and do not talk while taking a measurement.-only use the arm cuff on persons whose arm circumference is within the specified range of the cuff.-consult with your physician before using this monitor if you have severe blood flow problems or blood disorders as cuff inflation can cause bruising.Since there was no issue found with returned device; further investigation and correction is not necessary.

Manufacturer Narrative

Updated information section b3, d4, d9, g2, g6 h2 and h6.Additional information added to section h10.After initial report was submitted, the copy of the consumer's fda report was received on 10/7/2022.B3 was updated based on the date of the event listed on the report and additional codes were added to the health effect - clinical codes due to the consumer stating in her report that she had a restricted range of motion and her arm circumference had increased 1 inch due to the inflammation.The consumer also provided additionally in her report that she had applied an ice pack and had bed rest.The consumer returned the unit back to importer for evaluation.Section d4 serial number has been updated based on the unit received.The importer evaluated the returned unit and it passed evaluation.The returned unit has been sent to device manufacturer for further testing.An additional follow-up will be sent based on the manufacturer's investigation.

• Brand Name: 5 SERIES CONNECTED UPPER ARM BLOOD PRESSURE MONITOR
• Type of Device: BLOOD PRESSURE MONITOR
• Manufacturer (Section D): OMRON HEALTHCARE CO., LTD; 53 kunotsubo; terado-cho; muko-city, 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: 15549039
• MDR Text Key: 301239897
• Report Number: 8030245-2022-00007
• Device Sequence Number: 1
• Product Code: DXN
• UDI-Device Identifier: 00073796267254
• UDI-Public: (01)00073796267254
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133379
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: BP7250
• Device Catalogue Number: BP7250
• Device Lot Number: 202201V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female