MAUDE Adverse Event Report: OHIO MEDICAL LLC INSTAVAC; PORTABLE SUCTION PUMP

Model Number	756010
Medical Device Problem Codes	Mechanical Jam (2983); Suction Failure (4039)
Health Effect - Clinical Code	Airway Obstruction (1699)
Date of Event	12/04/2022
Type of Reportable Event	Death
Event or Problem Description
Complaint (b)(4) was received on december 8, 2022 which stated "unit was brought in during a code and was not operational/ no power.Another working unit was brought in.".
Additional Manufacturer Narrative
On december 21, 2022: discussion with pump manufacturer took place in which multiple failure modes for fractured vanes were outlined.On december 22, 2022: investigation (b)(4) was initiated.On december 19, 2022: (b)(6) contacted user facility requesting additional information which included details of the event, as well as usage and maintenance of the device.(b)(6) continued to follow up with the user facility by phone and email on december 21, 2022, december 27, 2022, december 29, 2022, and january 4, 2023.On january 5, 2023: response from user facility was received.The patient was not producing spontaneous pulse or breath, and patient projectile vomited which required use of the suction pump.Secondary device was put into use, but patient was not able to be resuscitated.Additional investigation is ongoing to determine definitive root cause.A follow up to this report will be submitted as required by 21 cfr 803 once additional information is obtained.
Event or Problem Description
This is a follow up to report submitted on january 06, 2023.
Additional Manufacturer Narrative
The following additional actions have taken place: january 3, 2023 - investigation (b)(4) concluded that manufacturer recommended pump maintenance was not included in ohio medical device instructions for use, and therefore not performed, resulting in clogged exhaust mufflers, increased pressure and cracked vanes.January 18, 2023 - health and hazard evaluation was completed, with corrections identified as revision of ohio medical instructions for use aligning preventive maintenance instructions with pump manufacturer recommendations.January 30, 2023 - pump manufacturer conducted evaluation of a sample of seized pumps and identified manufacturing defects within the pump component unrelated to preventive maintenance or device use.In one instance failure of the adhesive bond between the motor shaft and the rotor was noted, and another case identified an actual motor failure.Further investigation into both issues is required.It should be noted that product hold was initiated on december 20, 2022 for all potentially impacted part numbers.This hold will remain in place until definitive root cause, correction and corrective action is determined.

• Brand Name: INSTAVAC
• Common Device Name: PORTABLE SUCTION PUMP
• 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: 16126927
• Report Number: 1419185-2023-00001
• Device Sequence Number: 16975870
• Product Code: BTA
• UDI-Device Identifier: 00628101609504
• UDI-Public: 0100628101609504
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K933902
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 756010
• Device Catalogue Number: 756010
• Device Lot Number: INSTI22001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2022
• Supplement Date Received by Manufacturer: 12/08/2022
• Initial Report FDA Received Date: 01/09/2023
• Supplement Report FDA Received Date: 02/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown