MAUDE Adverse Event Report: COVIDIEN MX40 5 LEAD NON SPO2; CABLE, ELECTRODE

Model Number 33541

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/18/2019

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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

Customer reports the rhythm showed patient was in v-tach (ventricular tachycardia), however patient was not.

Manufacturer Narrative

Additional event information was provided by the initial reporter.

Event Description

Customer reported that while patient was wearing a philips mx40 telemetry transmitter with the adapter to monitor the heart while in the hospital.The rhythm showed patient was in v-tach (ventricular tachycardia), however patient was not.Additional information received on (b)(6) 2019 stated that when they thought the female patient with history of sepsis was in vtach, rapid response team was called.They brought in the crash cart, placed defibrillator pads on patient, ordered amiordarone (anti arythmic medication), then noticed the ekg on the defibrillator was normal.Took patient¿s blood pressure and brought in 12-lead ekg machine to perform resting ekg which was normal.End result was the patient was not in vtach, they did not apply energy nor did they administer amiordarone.Per hospital protocol, they transferred the patient to icu within the same hospital.

Manufacturer Narrative

Based on the supplier investigation, the device history record review did not indicate that there were any issues that could lead to the reported incident.One sample was returned for continuity testing.The test result show that the unit passed.Based on the results of the investigation, the root cause reported by the customer could not be determined.The reported condition could not confirm a manufacturing deficiency.If additional information is received warranting further analysis, the investigation may be resumed.This complaint will be used for tracking and trending purposes.

• Brand Name: MX40 5 LEAD NON SPO2
• Type of Device: CABLE, ELECTRODE
• Manufacturer (Section D): COVIDIEN; 15 hampshire st; mansfield MA 02048
• MDR Report Key: 8717574
• MDR Text Key: 148806463
• Report Number: 1282497-2019-08517
• Device Sequence Number: 1
• Product Code: IKD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 33541
• Device Catalogue Number: 33541
• Device Lot Number: 007539
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1