MAUDE Adverse Event Report: MANAMED PLASMAFLOW; SLEEVE, LIMB, COMPRESSIBLE

Model Number	PF0001
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Because the reporter chose to remain anonymous, we are unable to interview them or get the device back for analysis.We are therefore unable to confirm that the device failed to meet its specifications in any way.
Event or Problem Description
On 14-sep-2023, manamed received notification of report mw5145189 via medwatch.The following problem description was provided in that report: "using the plasma flow dvt prevention device and noticed it inflated to become like a tourniquet and was compressing my leg causing me to turn it off.I referred to the instructions provided that said it had an audible alarm which did not work.I inflated the device again and it failed to alarm a second time." no health effect was reported.The problem description states the device "inflated to become like a tourniquet", but does not provide any further detail to explain what this means.The device is designed to inflate and apply 55mmhg pressure to the patient's limb.The problem description also states that the audible alarm did not work.The alarm is designed to go off only if the battery is low or if the device fails to inflate.Neither of these conditions appear to have been present in this situation so the alarm should not have gone off.Because the reporter chose to remain anonymous, we are unable to interview them or get the device back for analysis.We are therefore unable to confirm that the device failed to meet its specifications in any way.
Additional Manufacturer Narrative
Udi related data quality updates only - 1.Only di portion of the udi is known for the suspect plasmaflow device.Pi portion of the udi was not reported and is unknown to manamed.2.Mdr originally filed as combo product, which did not match gudid.This mdr corrects that error.

• Brand Name: PLASMAFLOW
• Common Device Name: SLEEVE, LIMB, COMPRESSIBLE
• Manufacturer (Section D): MANAMED; 2612 sirius dr; denton TX 76208
• Manufacturer Contact: john beasley ; 2612 sirius dr; denton, TX 76208 ; 8885080712
• MDR Report Key: 17914658
• Report Number: 3011767724-2023-00002
• Device Sequence Number: 6636375
• Product Code: JOW
• UDI-Device Identifier: 00850998008003
• UDI-Public: 00850998008003
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K160318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2024

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: Lay User/Patient
• Device Model Number: PF0001
• Device Catalogue Number: PF0001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/11/2023
• Supplement Report FDA Received Date: 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown