MAUDE Adverse Event Report: OHIO MEDICAL LLC OHIO MEDICAL; OHIO MEDICAL LEGACY INTERMITTENT SUCTION UNIT

Model Number 1251

Device Problems Insufficient Information (3190); Device Handling Problem (3265)

Patient Problem Respiratory Arrest (4461)

Event Date 06/11/2021

Event Type  Death  

Manufacturer Narrative

Original event (as reported on (b)(4)) description: "respiratory arrest with patient having pooling of feculent vomit in oropharynx.Code team unable to emergently intubate due to no functioning wall-suction in the room.Per rt (respiratory therapist) and nursing staff, suction was not functioning.Portable suction was obtained by rt team, and patient was eventually intubated however not having suction available during respiratory arrest even during emergent intubation was a delay.Dart (distress activation response team) was called but prior to their arrival ett (endotracheal tube) was placed using portable suction obtained by rt.Patient ultimately died despite cpr and resuscitative efforts.Wall suction regulator malfunctioned.Wall suction functioning properly.Engineering reported to room and checked the report of no suction.Tech found a bad suction regulator on the wall tech, removed the regulator and installed test our test unit and found wall outlet to be working correctly.Tech informed nursing they needed to contact respiratory therapy for a replacement unit.Device failed." complaint data/ trends were analyzed and it was determined that frequency of what would be reported as "low or no vacuum" aligns with frequency rate as documented in device failure modes and effects analysis.Device instructions for use was reviewed and the following is stated "warning: the pre-use checkout procedure must be performed before using the equipment on each patient.If the regulator fails any part of the pre-use checkout procedure, it must be removed from service and repaired by qualified service personnel." the alleged failure (ohio medical was unable to replicate the failure in our testing of this device) described should have been identified during the pre-use checkout procedure.It is theorized based on results of device evaluation that this event occurred due to user error.It should be noted that while set to "intermittent" the device cycle begins in the "off" mode as specified in instructions for use.Other factors that would influence vacuum level would be improper connections between tubing, filter, vacuum regulator, collection bottle and trap jar or a full trap jar, which is intended to stop flow of vacuum in order to protect source pressure.Health and hazards evaluation was performed, with input provided from clinical representative.It was determined, based on result of device evaluation and review of failure occurence that no further action is required at this time.

Event Description

On may 9, 2022 - a request was received from (b)(4) of the us fda requesting additional information regarding user facility report (b)(4).Upon receipt of this request ohio medical complaint and adverse event data was reviewed and it was determined that ohio medical had not yet become aware of the event described.User facility initial reporter (b)(6) was immediately contacted by telephone to request return of the suspect device as well as any additional information that could be provided.

• Brand Name: OHIO MEDICAL
• Type of Device: OHIO MEDICAL LEGACY INTERMITTENT SUCTION UNIT
• Manufacturer (Section D): OHIO MEDICAL LLC; 1111 lakeside dr; gurnee IL 60031
• Manufacturer (Section G): OHIO MEDICAL LLC; 1111 lakeside dr; gurnee IL 60031
• Manufacturer Contact: jessica barrile ; 1111 lakeside dr; gurnee, IL 60031 ; 8478556318
• MDR Report Key: 14634952
• MDR Text Key: 293604090
• Report Number: 1419185-2022-00003
• Device Sequence Number: 1
• Product Code: KDP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 1251
• Device Catalogue Number: 6700-1251-900
• Device Lot Number: ISU141068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2022
• Date Manufacturer Received: 05/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 78 YR
• Patient Sex: Female