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U.S. Department of Health and Human Services

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

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COSTA MESA MFG DC HT70 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number HT70PM-JP-NA
Device Problems Accessory Incompatible (1004); Defective Alarm (1014)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/21/2020
Event Type  Malfunction  
Manufacturer Narrative

Medtronic conducted an investigation based upon all information received. The device was available for evaluation. The service personal(sp) inspected the unit and confirmed the reported issue. Sp replaced the control board and filter assembly to address the issue. Sp also performed the preventive maintenance (pm) and replaced the power pack battery, internal battery cooling fan and oxygen sensor. It was reported that during servicing, the inlet filter for this ht70 ventilator was damaged. Additionally, it was reported that there was no alarm sound generated during shutdown. The reported issue was/could not be confirmed. The most likely cause was isolated in the field to a potential fault in replaced components filter assembly and control board. The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it has met all medtronic quality specifications. If information is provided in the future, a supplemental report will be issued.

 
Event Description

It was reported that during servicing, the inlet filter for this ht70 ventilator was damaged. Additionally, it was reported that there was no alarm sound generated during shutdown. The ventilator was not in use on a patient at the time of the reported event.

 
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Brand NameHT70 VENTILATOR
Type of DeviceVENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
COSTA MESA MFG DC
1620 sunflower ave
costa mesa CA 92626
Manufacturer (Section G)
COSTA MESA MFG DC
1620 sunflower ave
costa mesa CA 92626
Manufacturer Contact
kelly adams
2101 faraday avenue
carlsbad, CA 92008
7606035046
MDR Report Key11263762
MDR Text Key233476679
Report Number2023050-2021-00005
Device Sequence Number1
Product Code CBK
Combination Product (Y/N)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 02/01/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/01/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberHT70PM-JP-NA
Device Catalogue NumberHT70PM-JP-NA
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/21/2020
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/06/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/01/2014
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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