MAUDE Adverse Event Report: WELCH ALLYN, INC. CONNEX SPOT MONITOR; MONITOR, PHYSIOLOGICAL, PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Calibration Problem (2890)

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

Event Date 05/10/2019

Event Type  malfunction  

Event Description

Temperature needs calibration.Temperature probe readings incorrect.

• Brand Name: CONNEX SPOT MONITOR
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): WELCH ALLYN, INC.; 4341 state street rd.; skaneateles falls NY 13153
• MDR Report Key: 8925336
• MDR Text Key: 155343508
• Report Number: 8925336
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/12/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/23/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1