MAUDE Adverse Event Report: SECHRIST INDUSTRIES, INC. 3500CP-G MIXER, GENERAL

Model Number 3500CP-G

Device Problem Failure to Deliver (2338)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2018

Event Type  malfunction  

Manufacturer Narrative

Customer service has contacted the customer for the return of the mixer for investigation but it has not been received to date.If and when the mixer is received a supplemental medwatch report will be submitted.A review of the device history records found the mixer model # 3500cp-g s.N.(b)(4) was manufactured on 04/20/2017.There is no indication that there were any relevant discrepancies during manufacturing.A review of the device history record (dhr) found no non-conformance that could cause or contribute to the reported issue.

Event Description

Customer reported that the desaturation of the o2 to the patient was due to the blender malfunctioning, since the flow was improperly administered due to mismatch of the mixer, there was no patient injury or delay in treatment due to this issue.Post event the customer reports that they reviewed the system and wiring and the oxygen source was changed and 100% f02 was placed for immediate improvement.Customer reports that they did a performance verification of the mixer prior to being placed into use with the patient, flow check of the mixer and measurement of the flows and fi02% were done.The customer reported the last preventative maintenance completed on the mixer was in march.

• Brand Name: 3500CP-G MIXER, GENERAL
• Type of Device: MIXER
• Manufacturer (Section D): SECHRIST INDUSTRIES, INC.; 4224 e. la palma avenue; anaheim CA 92807
• Manufacturer (Section G): SECHRIST INDUSTRIES, INC.; 4224 e. la palma avenue; anaheim CA 92807
• Manufacturer Contact: majid mashayekh ; 4224 e. la palma avenue; anaheim, CA 92807 ; 7145798309
• MDR Report Key: 7833599
• MDR Text Key: 119341147
• Report Number: 2020676-2018-00014
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K023745
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/01/2018

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
• Device Operator: Health Professional
• Device Model Number: 3500CP-G
• Device Catalogue Number: 3500CP-G
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/01/2018
• Initial Date FDA Received: 08/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 12 MO