MAUDE Adverse Event Report: MEDICAL FITTINGS, INC. OHMEDA 1251 CONTINUOUS/INTERMITTENT VACUUM REGULATOR; MEDI FITT/OHMEDA OXY/AIR/VAC&NIT-OXI MALE QK CONN

Model Number M3355

Device Problem Suction Problem (2170)

Patient Problem No Patient Involvement (2645)

Event Date 08/27/2019

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 that the relief hole was clogged and the intermittent timing assembly was bad.This confirmed the reported event.The timing assembly was replaced and adjusted.The relief hole was cleaned.The device was tested on a pump and passed the gauge, leak test - supply/patient side, regulation test, and visual inspection.The root cause for the reported repeated failures was determined to be the aged parts that were replaced.This type of event will continue to be monitored.

Event Description

Reportedly, post repair, the devices intermittent suction was not working as it would not go to 0 (zero).There was no patient involvement.No additional information is available.

• Brand Name: OHMEDA 1251 CONTINUOUS/INTERMITTENT VACUUM REGULATOR
• Type of Device: MEDI FITT/OHMEDA OXY/AIR/VAC&NIT-OXI MALE QK CONN
• Manufacturer (Section D): MEDICAL FITTINGS, INC.; 300 held dr.; northampton PA 18067
• 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: 9112784
• MDR Text Key: 167647984
• Report Number: 3007409280-2019-00025
• Device Sequence Number: 1
• Product Code: BYX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K904701
• 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: 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M3355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/27/2019
• 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