MAUDE Adverse Event Report: OHIO MEDICAL PRODUCTS OHMEDA 1251 CONTINUOUS/INTERMITTENT VACUUM REGULATOR; FREE FLOW VACUUM REGULATOR

Model Number FROM1600

Device Problem Calibration Problem (2890)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/05/2019

Event Type  malfunction  

Manufacturer Narrative

The complaint device was returned for evaluation.Incoming visual inspection did not identify any anomalies.Technical visual inspection did not identify any anomalies.Device evaluation found the timing was off.The timing was adjusted.The device was calibrated.Leak test and suction accuracy was tested and passed.The gauge test, leak test - supply/patient side, regulation test in both modes all passed.The final visual inspection was good.A definitive root cause cannot be determined; however, the reported issue was most likely due to the pressure sensor falling out of calibration.This was not related to the previous repair.This type of event will continue to be monitored.

Event Description

Reportedly, post repair, the device gauge goes all the way around when the suction is turned to full and its port is open.It is unknown if there was patient involvement.There was no patient harm reported.No additional information available.

• Brand Name: OHMEDA 1251 CONTINUOUS/INTERMITTENT VACUUM REGULATOR
• Type of Device: FREE FLOW VACUUM REGULATOR
• Manufacturer (Section D): OHIO MEDICAL PRODUCTS; 803 n. front st. suite 3; mchenry IL 60050
• Manufacturer (Section G): AVANTE HEALTH SOLUTIONS; 212 avenida fabricante; san clemente CA 92672
• Manufacturer Contact: jenna vargas ; 212 avenida fabricante; san clemente, CA 92672 ; 8004495328
• MDR Report Key: 9216422
• MDR Text Key: 177833508
• Report Number: 3007409280-2019-00044
• Device Sequence Number: 1
• Product Code: KDP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K801169
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FROM1600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1