MAUDE Adverse Event Report: COVIDIEN KENDALL DL ADAPTER PHILIPS 3 5 LD; CABLE, ELECTRODE

Model Number 33507

Device Problem Low Readings (2460)

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

Event Date 03/19/2021

Event Type  malfunction  

Manufacturer Narrative

The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.

Event Description

The customer reported that one patient was showing a heart rate in the 30's.The nurse almost pushed atropin and another nurse stated she checked the leadwires and "manipulated" the pink adapter connected to the monitor and the patient's rhythm then started to show it was 88.No patient injury was reported.

Manufacturer Narrative

A device history record review could not be performed on the reported device because a lot number was not received with the complaint.The supplier received six adapters of item code 33507 and one cable of item code 33135t for evaluation.After reviewing the returned samples, the lot number was not able to be found on the adapters.The lot number of the cable was determined to be 072538.The device history record for the cable was reviewed and there have been no process changes (including injection parameters/tooling/ injection equipment).The supplier performed an electronic test on the adapters and cable under current mass production test conditions.The samples passed the test and were found to be in good condition.Based on the available information the supplier was unable to determine a root cause therefore no corrective action will be taken at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: KENDALL DL ADAPTER PHILIPS 3 5 LD
• Type of Device: CABLE, ELECTRODE
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11640996
• MDR Text Key: 244654332
• Report Number: 1282497-2021-10041
• Device Sequence Number: 1
• Product Code: IKD
• UDI-Device Identifier: 10884527021475
• UDI-Public: 10884527021475
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 33507
• Device Catalogue Number: 33507
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/22/2021
• Patient Sequence Number: 1