MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA TEMPERATURE SENSOR; DISPOSABLE TEMPERATURE PROBES

Catalog Number MX11001

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation is still ongoing.The results will be provided within a follow-up report.

Event Description

It was reported that during a running incubator operation the probe of the temperature sensor which was stuck to the babies back fragmented itself without applied force.This was detected accidentally as the baby was holding the detached metal part in its hand.No injury reported.

Event Description

Please refer to the initial-report.

Manufacturer Narrative

A thermotrace peripheral temperature probe was made available for the purposes of the investigation and was subjected to an optical analysis.This confirmed that the metal plate had become detached, as had been reported initially.The temperature probes are designed to be used on a single patient and must not be disinfected or sterilized because this can lead to the failure of the products, as described in the instructions for use.The instructions for use stipulate that all component parts must be regularly checked for damage or any external signs of wear, such as cracking, brittleness or significant hardening, as well as for any residual contamination.According to the customer, kodan is used to clean the probe when there is visible external contamination; this is not permissible and is regarded as the cause of the metal plate becoming detached as a result of the substance penetrating the probe.The temperature probe is attached to the patient¿s skin using special adhesive pads.If a metal plate becomes potentially detached, it will be fixed in place by the adhesive pad and then reliably detected when the next check is carried out or when a pad is removed in order to position it elsewhere.In the case in question, the adhesive pad appears to have become detached of its own accord given that the metal plate is reported to have been found in the baby¿s hand.It was reported that oils are used for skincare purposes.It is thus conceivable that this contributed to the detachment of the adhesive pad.In principle, the lack of metal plate does not have any impact on the temperature measurement.It serves only to ensure the even transmission of temperature from skin to sensor, which is why no alarm is generated in this case by the main device connected.Because we are not aware of any other similar complaints of this issue, we regard this as an isolated case.Roughly 100,000 units with five sensors each are sold every year.

• Brand Name: TEMPERATURE SENSOR
• Type of Device: DISPOSABLE TEMPERATURE PROBES
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 8216360
• MDR Text Key: 132922825
• Report Number: 9611500-2019-00001
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• PMA/PMN Number: -
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/01/2019

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 Operator: Health Professional
• Device Expiration Date: 01/01/2000
• Device Catalogue Number: MX11001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/06/2018
• Initial Date FDA Received: 01/04/2019
• Supplement Dates Manufacturer Received: 03/01/2019
• Supplement Dates FDA Received: 03/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1