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U.S. Department of Health and Human Services

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

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OMRON HEALTHCARE CO., LTD. MATSUSAKA FACTORY EVOLV UPPER ARM BLOOD PRESSURE MONITOR Back to Search Results
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.
 
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Brand NameEVOLV UPPER ARM BLOOD PRESSURE MONITOR
Type of DeviceBLOOD 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 Key7949205
MDR Text Key123366880
Report Number9611045-2018-00001
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162092
Number of Events Reported1
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 Received10/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberBP7000
Device Catalogue NumberBP7000
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Distributor Facility Aware Date09/06/2018
Event Location No Information
Date Manufacturer Received11/12/2018
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

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