MAUDE Adverse Event Report: CRITIKON DE MEXICO S. DE R.L. DE C.V. ONE-CUF; BLOOD PRESSURE CUFF

Model Number	ONE-A2-2A
Medical Device Problem Codes	Low Readings (2460); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Legal manufacturer: hcs research park - 9900 innovation drive usa wauwatosa, wi 53226 a1-6: not provided by customer.B3: not available at this time.Ge healthcare's investigation is on-going at this time.A follow-up report will be submitted when the investigation is completed.
Event or Problem Description
It was reported that a patient was unnecessarily treated for incorrectly low nibp readings.The patient did not sustain any injury due to the alleged unnecessary medical treatment.The ge healthcare one-cuf nibp cuff was connected to a non-gehc (philips) patient monitor.
Additional Manufacturer Narrative
The actual one-cuf blood pressure cuff associated with this event was discarded by the customer.Other customer samples were returned to ge healthcare (gehc) for evaluation.Gehc investigated by testing returned samples, interviewing the customer, and performing historical data analysis.The investigation concluded that there was potential for device failures on this cuff design.To address the issues identified, gehc initiated a safety recall (fmi 39005) to remove all one-cuf blood pressure cuffs from the field.H9: the correction/removal report number has not yet been by provided by the agency.
Additional Manufacturer Narrative
This supplement is submitted to correct the udi.D4: the udi is (b)(4).

• Brand Name: ONE-CUF
• Common Device Name: BLOOD PRESSURE CUFF
• Manufacturer (Section D): CRITIKON DE MEXICO S. DE R.L. DE C.V.; calle valle del cedro 1551; juarez 32575 ; MX 32575
• Manufacturer (Section G): CRITIKON DE MEXICO S. DE R.L. DE C.V.; calle valle del cedro 1551; juarez 32575 ; MX 32575
• Manufacturer Contact: kristof soos ; 8200 w tower ave; milwaukee, WI 53223
• MDR Report Key: 18955558
• Report Number: 3008729547-2024-00002
• Device Sequence Number: 21173354
• Product Code: DXQ
• UDI-Device Identifier: 00195278571397
• UDI-Public: 00195278571397
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K230145
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: ONE-A2-2A
• Device Lot Number: 163232152
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/29/2024; Not provided; Not provided
• Initial Report FDA Received Date: 03/21/2024
• Supplement Report FDA Received Date: 05/30/2024; 07/03/2024; 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2027-2024
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown