MAUDE Adverse Event Report: COSTA MESA MFG DC HT70 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	HT70 VENTILATOR
Medical Device Problem Codes	No Flow (2991); Pressure Problem (3012)
Health Effect - Clinical Codes	Pneumothorax (2012); Low Oxygen Saturation (2477)
Date of Event	06/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The ht70 ventilator was returned to medtronic for evaluation.An investigation was performed and the circuit check failures were con firmed in the event history logs only.The popping noise issue could not be duplicated.A different issue was observed during testing, where the unit did not pass the system leak test.It was observed that the safety valve was partially pressed outside the manifold body.When the safety valve was pressed back into the manifold body and the pump/manifold assembly was re-installed, the unit ran with no alarms or errors.When the manifold assembly was replaced with a known working part, the unit continued to not pass the system leak test (although the leak value was lower).The pump assembly was removed and examined.No tears were observed in the diaphragm.A small amount of contamination/debris was observed under the check valves.The o-ring on the outlet end of the pump was observed to be damaged.The system leak was determined to potentially be caused by the safety valve pressed out of the manifold body, contamination under the check valves of the pump assembly, and a damaged o-ring.The pump/manifold assembly was noted to require replacement and the unit was going to be processed under service instructions.The unit would be returned to the loaner pool once the repairs are completed.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The reporter stated that a pre-intubation chest x-ray was obtained showing no pneumothorax.The patient was intubated and placed on the ht70 ventilator which began making a ¿popping noise¿ from the exhalation valve and generated high pressure alarms.It was reported that the patient had no chest rise and desaturated.The patient was bagged and placed on an alternate ventilator.A follow up chest x-ray showed a tension pneumothorax.After patient transfer, the staff powered the ventilator back on and attempted to run a circuit check which did not pass.

• Brand Name: HT70 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COSTA MESA MFG DC; 1620 sunflower ave; costa mesa CA 92626
• MDR Report Key: 8888010
• Report Number: 2023050-2019-00035
• Device Sequence Number: 2119244
• Product Code: CBK
• UDI-Device Identifier: 10884521208940
• UDI-Public: 10884521208940
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K111146
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/13/2019

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
• Operator of Device: Health Professional
• Device Model Number: HT70 VENTILATOR
• Device Catalogue Number: DLHT70PM-WW-NA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2019
• Initial Report FDA Received Date: 08/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 59