VAC PAC SIZE 30

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.

Description of Event or Problem

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.

Description of Event or Problem

VAC PAC SIZE 30 - INJURIES OCCUR AT PRESSURE POINTS SUCH AS BONY PROMINENCES. 2 LOTS WERE IDENTIFIED, DOCUMENTING THE 2ND LOT.