MAUDE Adverse Event Report: COMPASS HEALTH BRANDS (DISTRIBUTION CENTER) MERIDIAN; 8" APM WITH FOAM TUBE

Model Number 4580P

Device Problem Device Operational Issue (2914)

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

Event Type  malfunction  

Event Description

The technician states that the apm power button is on, and the rotator valve turns on, but nothing is happening.Nothing is reported as being wrong with the apm's fuses, internal wiring, or power cord.The device involved with this complaint was returned to compass health brands and evaluated on 6/19/2017.The customer's complaint could be confirmed.The returned unit was disassembled, and all connections and fuses were tested - everything was verified as good.The rotary valve switch was also tested to be in good, working order.The potential root cause of this malfunction is likely the circuit board, as determined by process of elimination.The returned device has since been scrapped following its evaluation.

• Brand Name: MERIDIAN
• Type of Device: 8" APM WITH FOAM TUBE
• Manufacturer (Section D): COMPASS HEALTH BRANDS (DISTRIBUTION CENTER); 18901 snow rd. bldg 6; brookpark OH 44142
• Manufacturer (Section G): COMPASS HEALTH BRANDS (DISTRIBUTION CENTER); 18901 snow rd. bldg 6; brookpark OH 44142
• Manufacturer Contact: kaycee nichols ; 6753 engle road; middleburg heights, OH 44130 ; 4402682579
• MDR Report Key: 6705825
• MDR Text Key: 80060104
• Report Number: 3005182235-2017-00001
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/12/2017

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: Other
• Device Model Number: 4580P
• Device Catalogue Number: 4580P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/13/2017
• Initial Date FDA Received: 07/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2016
• 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