MAUDE Adverse Event Report: OMRON HEALTHCARE CO., LTD. MATSUSAKA FACTORY EVOLV UPPER ARM BLOOD PRESSURE MONITOR

Model Number BP7000

Device Problems Overheating of Device (1437); Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4). The consumer was sent a replacement unit to facilitate in obtaining additional information to further investigate this incident. The u. S importer is requesting the manufacturer of the device to further investigate this incident. A root cause has not been determined. It has not been confirmed that the blood pressure monitor caused or contributed to the reported incident. However, if the device did malfunction, there is a potential for harm. Therefore, this medwatch is being filed.

Event Description

Consumer reported he recently received the evolv wireless blood pressure monitor as a birthday gift. He put the batteries in the unit and went to use the bathroom; when he came back there was a hot liquid coming out of the unit and it started smoking. Eventually, the unit was on fire and it basically burnt up the whole device. The consumer wrote that he was disappointed and upset about it, especially because it was a gift. It jeopardized the safety of his family. His wife is pregnant and he has children. One of his children has asthma and it is ridiculous and unacceptable that this even happened in the first place. He is still at a loss of words over this whole incident and it was completely unacceptable. He had to dispose of the unit due to the smoke aroma which was in the device and his house. The quality analyst emailed the consumer requesting a call back to obtain additional information regarding the report. The consumer sent an email to the quality analyst. In the email, the consumer wrote that he does not think he can get a refund since he received the unit as a gift. He had just received the unit and had not even used it for one day. He was only user and received the unit brand new. The unit was very hot and contained a smell and there was smoke. There was no personal injury from the incident and the only property damage was to his carpet. The consumer wrote that he unfortunately no longer has the blood pressure monitor in his possession. The consumer emailed again and stated that he would like a replacement unit and tracking information for the replacement unit sent by email. On 10/08/2018, the quality manager emailed the consumer again requesting the consumer to call back in order to obtain additional information. As of 10/09/2018, no further information has been received.

• Brand Name: EVOLV UPPER ARM BLOOD PRESSURE MONITOR
• Type of Device: BLOOD PRESSURE MONITOR
• Manufacturer (Section D): OMRON HEALTHCARE CO., LTD. MATSUSAKA FACTORY; 1855-370; kubo-cho; matsusaka mie, 51585 0300; JA 515850300
• Manufacturer (Section G): OMRON HEALTHCARE CO., LTD. MATSUSAKA FACTORY; 1855-370; kubo-cho; matsusaka mie, 51585 0300; JA 515850300
• Manufacturer Contact: renee thornborough ; 1925 w field court; suite 100; lake forest, IL 60045-4824 ; 8472475626
• MDR Report Key: 7949205
• MDR Text Key: 123366880
• Report Number: 9611045-2018-00001
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 09/06/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: BP7000
• Device Catalogue Number: BP7000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Distributor Facility Aware Date: 09/06/2018
• Event Location: No Information
• Date Manufacturer Received: 11/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial