MAUDE Adverse Event Report: LEONHARD LANG GMBH SKINTACT; ECG ELECTRODE

Model Number PD50-SF

Device Problem Detachment Of Device Component (1104)

Patient Problem Suffocation (2088)

Event Type  malfunction  

Event Description

On (b)(6), we have been informed by (b)(6) about a near incident during the use of a neonatal ecg electrode set at hospital (b)(6).The ecg electrodes (pd50-sf) were applied to a premature baby (born in the (b)(6) week of pregnancy).A nurse found a disc shaped element of one electrode (a printed label) in the mouth of the baby.This constitutes a potential suffocation hazard for the baby.No further info on the baby has been disclosed to us.

Manufacturer Narrative

During an internal audit, we have reviewed our complaint database and realized that we had missed reporting this near incident to the fda.As we have never supplied electrodes of that design (neonatal electrodes with a fixed lead) to the use so far, it was initially determined that the near incident was not reportable.However, the product is covered under an existing 510k and we therefore file this report.An investigation was performed to determine the likelihood of a re-occurrence.For this purpose retained lots of samples from each month of 2013 were examined.Some of the labels did not fully adhere to the electrodes over their entire surface.However, in each case force needed to be applied to tear the label from the electrode.The near incident was classified as a singular event with a very low repeat probability.No field action was initiated.In order to improve the design of the product, the specification of the label has been modified.Effective (b)(6) 2014, a soft foam material is used to replace the plastic film as a label on all neonatal and pediatric electrodes with fixed lead.This foam material adheres and conforms so well to the electrode and the lead that it cannot be separated from the electrode.

• Brand Name: SKINTACT
• Type of Device: ECG ELECTRODE
• Manufacturer (Section D): LEONHARD LANG GMBH; archenweg 56; innsbruck 6020 ; AU 6020
• Manufacturer Contact: burrhus lang ; archenweg 56; innsbruck 6020 ; AU 6020 ; 12334257
• MDR Report Key: 3888226
• MDR Text Key: 4678276
• Report Number: 8020045-2014-00004
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K08/0106
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Model Number: PD50-SF
• Device Lot Number: 30712-0762
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 2 DA