MAUDE Adverse Event Report: SECHRIST INDUSTRIES, INC. VENTILATOR, CONTINUOUS, FACILITY USE

Model Number IV100B

Device Problems Sticking (1597); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 08/19/2015

Event Type  malfunction  

Manufacturer Narrative

The investigation is currently underway.Once complete, a follow up report will be submitted.

Event Description

The customer reported that, "manometer was stuck at "-8" out of box.When unit was running, the manometer was not moving at all and he zeroed it with a screw driver, tapped on it and it popped free.A few times, he set the alarm for 30 seconds, but it did not go off until one and a half minute later or not at all." no patient involved.

Manufacturer Narrative

The reported unit was returned.A visual and functional evaluation was unable to duplicate the reported issue.The unit was calibrated and returned to the customer.No patient involvement.A review of the device history record (dhr) found no nonconformance that could cause or contribute to the reported issue.The service history on file with the manufacturer for the reported device did not show any issue that was applicable to the reported issue.A review of the complaint history indicates there is no significant trend.Trending will continue to be monitored.A review of the warning label in the user's manual states: "the performance verification procedure provides a means of determining whether the sechrist model iv-100b infant ventilator meets its design specifications.It is intended to be performed in the hospital by qualified technical personnel.This procedure should be performed prior to every time the ventilator is intended to be placed on a new patient or at least once a month or more frequently if desired." instructions in the manual states, "if the ventilator fails to meet any design specification, it should be removed from us; service may be required.".

• Brand Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): SECHRIST INDUSTRIES, INC.; anaheim CA
• Manufacturer Contact: mdr contact ; 4225 east la palma ave.; anaheim, CA 92807 ; 7145798400
• MDR Report Key: 5094842
• MDR Text Key: 26493887
• Report Number: 2020676-2015-00037
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K920121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Followup
• Report Date: 11/17/2015

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
• Device Operator: Health Professional
• Device Model Number: IV100B
• Device Catalogue Number: IV100B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/1984
• 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