MAUDE Adverse Event Report: CAREFUSION, INC MASTERSCREEN IOS; SPIROMETER, DIAGNOSTIC

Model Number MASTERSCREEN IOS

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/11/2014

Event Type  Injury  

Manufacturer Narrative

This mdr is being submitted due to a retrospective complaint review performed by carefusion.The carefusion identification file is (b)(4).A carefusion field service engineer evaluated the device at the customer's facility and found the screws had been stripped.The screws were replaced and the arm is now functioning as intended.(b)(4).

Event Description

It was reported via a carefusion field service engineer that the customer stated the arm holding the impulse oscillometer (ios) head became disconnected from the cart and fell onto the patient's lap during testing.The patient was a large male and he caught the ios/arm assembly.There was no harm done to the patient.

• Brand Name: MASTERSCREEN IOS
• Type of Device: SPIROMETER, DIAGNOSTIC
• Manufacturer (Section D): CAREFUSION, INC; liebnizstrasse 7; hoechberg 97204 ; GM 97204
• Manufacturer (Section G): CAREFUSION, INC; liebnizstrasse 7; hoechberg 97204 ; GM 97204
• Manufacturer Contact: jill rittorno ; 22745 savi ranch parkway; yorba linda, CA 92887 ; 7149227830
• MDR Report Key: 5540136
• MDR Text Key: 41780893
• Report Number: 9615102-2016-00001
• Device Sequence Number: 1
• Product Code: BZG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101873
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MASTERSCREEN IOS
• Device Catalogue Number: 001-176450
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other