MAUDE Adverse Event Report: RESPIRONICS EMERSON CA-3200 COUGH ASSIST MACHINE PORTABLE PATIENT RESPIRATORY AIR OXYGEN; POSITIVE PRESSURE BREATHING

Model Number CA-3200

Device Problems Failure to Power Up (1476); Device Inoperable (1663); Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/04/2017

Event Type  malfunction  

Event Description

I ordered a cough assist, ca-3200 respiratory machine from an authorized dealer from the (b)(6).I bought it off (b)(6) and they stated that the machine was completely refurbished and in excellent working condition.Total cost for machine, hoses and mask, and step up transformer, about (b)(6) dollars.The machine is faulty, does not work at all, won't even turn on.My father has muscular dystrophy and is 100 percent disabled and has breathing problems that this machine could help with.

• Brand Name: EMERSON CA-3200 COUGH ASSIST MACHINE PORTABLE PATIENT RESPIRATORY AIR OXYGEN
• Type of Device: POSITIVE PRESSURE BREATHING
• Manufacturer (Section D): RESPIRONICS
• MDR Report Key: 6575506
• MDR Text Key: 75529843
• Report Number: MW5069832
• Device Sequence Number: 1
• Product Code: NHJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 05/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CA-3200
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: OTC MEDS: NONE; RX MEDS: GABAPENTIN 100MG 10 A DAY.
• Patient Age: 87 YR
• Patient Weight: 91