MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED VAC PAC SIZE 30

Model Number	51630
Medical Device Problem Code	Component or Accessory Incompatibility (2897)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	02/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial report ref natus complaint#(b)(4).Per (b)(4) rev e vac-pac risk analysis hazard 13.3 - delayed/interrupted treatment.Vac-pac doesn't provide complete support cause - inappropriate size of vac-pac used residual risk - low.The hazards identified are associated with delayed/interrupted treatment of the patient due to inappropriate size of vac-pac used.The user is instructed to select a vac-pac that is appropriate for the procedure and patient's size.The user is also instructed that an incorrect size of vac pac will decrease patient stability.The benefits associated with the use of the vac-pac device outweigh the residual risk associated with these hazards.Technical service sent the ae questionnaire to the customer for completion as injuries were reported.The customer reported that they were requesting educational information.Technical service resent the questionnaire to the customer.May-28-2024 no further follow up action has been recorded or cross referenced in the service call for at least 45 days.Technical service made multiple attempts for the return of the ae questionnaire and defective part.Review of the customer's account found no additional related calls.No related capas.Further review of details to be carried out before final closure.
Event or Problem Description
Vac pac size 30 - injuries occur at pressure points such as bony prominences.
Additional Manufacturer Narrative
Follow up report 001 ref natus complaint#(b)(4).Install date of part:(b)(6) 2023.The complaint case is now closed.Failure confirmed: no.Investigation result code: neuro sbu|product not returned.
Event or Problem Description
Vac pac size 30 - injuries occur at pressure points such as bony prominences.2 lots were identified, documenting the 2nd lot.

• Brand Name: VAC PAC SIZE 30
• Common Device Name: VAC PAC SIZE 30
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED; dba excel-tech ltd.; 2568 bristol circle; oakville, ontarios, L6H 5 S1; CA L6H 5S1
• Manufacturer (Section G): NATUS MANUFACTURING LIMITED; ida business park; gort; galway h91pd92, ; EI
• Manufacturer Contact: gráinne walsh ; dba excel-tech ltd.; 2568 bristol circle; oakville, ontarios, L6H 5-S1 ; CA L6H 5S1
• MDR Report Key: 19414634
• Report Number: 9612330-2024-00031
• Device Sequence Number: 8747408
• Product Code: CCX
• UDI-Device Identifier: 00382830005395
• UDI-Public: 00382830005395
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: 51630
• Device Catalogue Number: 51630
• Device Lot Number: N041223-12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/28/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/29/2024
• Supplement Report FDA Received Date: 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown