MAUDE Adverse Event Report: INNOVATION LLC REGARD; DISPOSABLE NEO SOFT CUFF #1 3-6 CM

Model Number	BPNEO1-REG
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that usa health is getting high blood pressure readings on our size neo 1 bp cuffs, while there is no reported harm to patient an inaccurate reading could lead to a mis diagnosis/ inappropriate medical management.
Additional Manufacturer Narrative
The product involved in the report has not been returned.A review of the device history record is in-progress all information reasonably known as of 15 aug 2025 has been included in the health authority report.Should additional information be obtained a follow-up health authority report will be provided.The information provided by airlife.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to airlife.Airlife has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the airlife complaint database and is identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a airlife product is defective or causes serious injury.
Additional Manufacturer Narrative
The product involved in the report has not been returned.A review of the device history record is in-progress.All information reasonably known as of 15 aug 2025 has been included in the health authority report.Should additional information be obtained a follow-up health authority report will be provided.The information provided by airlife.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to airlife.Airlife has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the airlife complaint database and is identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a airlife product is defective or causes serious injury.The complaint of "getting high blood pressure readings on our size neo 1 bp cuffs" regarding part bpneo1-reg was confirmed.The root cause was determined to be a design issue.A risk assessment was performed, and the ultimate risk was determined to be low which does not require escalation to the capa review board.There have been 0 other complaints regarding the same part and a similar issue within the 24 months preceding this reported event.Corrective actions will be implemented as part of project code eng 16.Complaints will continue to be monitored for possible trends.
Event or Problem Description
It was reported that usa health is getting high blood pressure readings on our size neo 1 bp cuffs, while there is no reported harm to patient an inaccurate reading could lead to a mis diagnosis/ inappropriate medical management.

• Brand Name: REGARD
• Common Device Name: DISPOSABLE NEO SOFT CUFF #1 3-6 CM
• Manufacturer (Section D): INNOVATION LLC; 1100 dr martin luther king jr; blvd suite 1100; nashville TN 37203
• Manufacturer (Section G): SUNMED AP, LTD.; 6-9 zhufeng rd., qiannan indus; qianwu town, doumen district; zhuhai guangdong, china 51917 0; CH 519170
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 22822409
• Report Number: 1314417-2025-00060
• Device Sequence Number: 17284281
• Product Code: DXQ
• UDI-Device Identifier: 10326053121668
• UDI-Public: (01)10326053121668(10)250100534
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K921997
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2025

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: Health Professional
• Device Model Number: BPNEO1-REG
• Device Catalogue Number: BPNEO1-REG
• Device Lot Number: 250100534
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2025
• Supplement Date Received by Manufacturer: 04/08/2025
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown