MAUDE Adverse Event Report: NAVILYST MEDICAL NAMIC; TRANSDUCER, BLOOD-PRESSURE

Model Number H749602301480

Device Problem Failure to Reset (1532)

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

Event Date 01/22/2014

Event Type  malfunction  

Event Description

The nurse connected the transducer from the convenience kit to the pressure cable and the line to the patient.The nurse attempted to zero and could not.She tried different connections on the ge tram module and still it failed to zero.She used a different transducer separately packaged (a transducer by itself) and she was able to zero the transducer and continue with the case.

• Brand Name: NAMIC
• Type of Device: TRANSDUCER, BLOOD-PRESSURE
• Manufacturer (Section D): NAVILYST MEDICAL; 26 forest st; marlborough MA 01752
• MDR Report Key: 3596441
• MDR Text Key: 19728965
• Report Number: 3596441
• Device Sequence Number: 1
• Product Code: DRS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 01/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: H749602301480
• Device Catalogue Number: 60230148
• Device Lot Number: 4697711
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/28/2014
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/29/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GE MACLAB, GE TRAM UNIT