MAUDE Adverse Event Report: WELCH ALLYN INC VITAL SIGNS MONITOR; BLOOD PRESSURE CUFF

Model Number VSM300

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Laceration(s) (1946)

Event Date 02/07/2018

Event Type  malfunction  

Event Description

Rn was taking off the blood pressure connector from patient's blood pressure cuff and it broke off and cut rn on finger.Injury status unknown.Work order placed; biomed states that there have been multiple issues with these connector pieces but unaware of any staff being harmed by them.

• Brand Name: VITAL SIGNS MONITOR
• Type of Device: BLOOD PRESSURE CUFF
• Manufacturer (Section D): WELCH ALLYN INC; 4341 state street rd.; skaneateles falls NY 13153
• MDR Report Key: 7458120
• MDR Text Key: 106432627
• Report Number: 7458120
• Device Sequence Number: 1
• Product Code: DXQ
• Combination Product (y/n): N
• 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: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: VSM300
• Other Device ID Number: 20099414
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/12/2018
• Event Location: Hospital
• Date Report to Manufacturer: 04/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1