MAUDE Adverse Event Report: MINDRAY DS USA, INC GAS MODULE 3; SPIROMETER, MONITORING

Device Problem Connection Problem (2900)

Patient Problem No Information (3190)

Event Date 02/15/2014

Event Type  malfunction  

Event Description

We have had 4 repairs on this gas module for anesthesia in 4 years, all having to do with the gas module not electronically connecting to the mindray spectrum or 1 monitor.When we return the unit to mindray they do not find any problems and send the unit back.Each time it is returned it works for a period of time and then fails again.
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manufacturer response for anesthesia co2 monitoring module, mindray gas module 3 (per site reporter).
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mindray has given the hospital a verbal agreement to provide the hospital with a replacement gas module 3.

• Brand Name: GAS MODULE 3
• Type of Device: SPIROMETER, MONITORING
• Manufacturer (Section D): MINDRAY DS USA, INC; 800 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 3659157
• MDR Text Key: 4351561
• Report Number: 3659157
• Device Sequence Number: 1
• Product Code: BZK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2014
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/04/2014
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/05/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1