MAUDE Adverse Event Report: LYNN MEDICAL INSTRUMENT CO ACCUSENSOR; ELECTRODE, ELECTROCARDIOGRAPH

Model Number P-50

Device Problem Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/16/2022

Event Type  malfunction  

Event Description

Several ekg stickers used in nuclear medicine have missing plastic nipple that allows for clipping to ekg.Accusensor diagnostic radiotranslucent ecg electrode lynn medical p-50 60 electrodes, lot# 212368.Staff have been experiencing this for one month but just escalated it.Pictures embedded in this report.

• Brand Name: ACCUSENSOR
• Type of Device: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): LYNN MEDICAL INSTRUMENT CO; 50120 pontiac tr; po box 930459; wixom MI 48393
• MDR Report Key: 14521667
• MDR Text Key: 292801045
• Report Number: 14521667
• Device Sequence Number: 1
• Product Code: DRX
• 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: 05/19/2022

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 Model Number: P-50
• Device Catalogue Number: P-50
• Device Lot Number: 212368
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/19/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/27/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/27/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other