MAUDE Adverse Event Report: CAREFUSION, INC MARK 7; MIXER, BREATHING GASES, ANESTHESIA INHALATION

Model Number MARK 7

Device Problems Incorrect Measurement (1383); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 03/28/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Any additional information received from the customer will be included in a follow-up report.(b)(4).Results of investigation: the carefusion manufacturing service group received the suspect mark 7 respirator device for investigation.The mark 7 was visually and physically inspected, which found the pressure manometer reading 15 cmh2o on the device.The reported event of the device failing to cycle off was not duplicated, therefore no component failure investigation was performed and no root cause can be determined.The manometer gauge failure was confirmed and a replacement pressure manometer was installed on the device.The device was tested, which met manufacture specifications, so no further investigation will be required.

Event Description

The customer reported the pressure manometer was stuck reading 15 cmh20 and would not cycle off a pressure breath on this mark 7 respirator.No known reported patient involvement with this event.

• Brand Name: MARK 7
• Type of Device: MIXER, BREATHING GASES, ANESTHESIA INHALATION
• Manufacturer (Section D): CAREFUSION, INC; 22745 savi ranch parkway; yorba linda CA 92887
• Manufacturer (Section G): CAREFUSION, INC; 1100 bird center dr.; palm springs CA 92262
• Manufacturer Contact: kristin graf ; 22745 savi ranch parkway; yorba linda, CA 92887
• MDR Report Key: 6526820
• MDR Text Key: 74014879
• Report Number: 2021710-2017-05831
• Device Sequence Number: 1
• Product Code: BZR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/27/2017

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: MARK 7
• Device Catalogue Number: 07100A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2017
• Initial Date FDA Received: 04/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2005
• 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