MAUDE Adverse Event Report: COVIDIEN FSE 2100 SAFELINC SGL HEL 50/C; FETAL ELECTRODE

Model Number 31479549

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 08/21/2015

Event Type  malfunction  

Manufacturer Narrative

Submit date: 09/22/2015.An investigation is currently under way; upon completion the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2015 that a customer had an issue with a fetal scalp electrode.The customer reports the fetal spiral electrodes (fse) have failed.As a result we would likely replace the fse each time this occurs.Every time the fse is placed there is a break in the skin of the fetus which poses a potential for infection or bleeding.

Manufacturer Narrative

Per lead clinical analyst, upon further assessment of the risk file for this product along with additional clinical evaluation of this specific event, this would not be a reportable event.The lot number for this complaint was provided and a review of a device history record from the same time period has been performed; no peculiarities were noted and all product requirements were met.Prior to a lot being released, it must be deemed acceptable by passing 100% continuity for both the infant and maternal monitoring during in-process inspection.Current manufacturing practices require production to be sampled and inspected based on valid sampling plans.These sampling plans have been reviewed as part of the investigation and have been found to meet the outgoing acceptable quality level (oaql).In addition to sampling and testing, production employees also perform 100% visual inspection as part of manufacturing requirements.Samples were received with this complaint number, consisting of 1-opened pouch with 1- used fse 2100 safelinc sgl hel 50/c 31479549, (inside a ziploc polybag) of the lot 507108x associated with this complaint that were tested for reading issues and met all requirements, and the reported issue could not be confirmed.The root cause identified is a worn out monitor cable.This attributed to a poor connection and therefore no reading.There have been no design changes to this product within the past year that would contribute to any increased probability for no reading.Production controls are in place to reduce and/or eliminate the possibility of electrode problems that could lead to latent issues such as no reading.An in-servicing visit was scheduled for this client and during the field visit complaint samples collected on site were tested using medtronic¿s monitor, simulator and cable and a trace was able to be obtained.From additional information received from the customer, the unit nurses provided additional details of the failures and a particular room was identified as having recurring issues.The customer reported that biomed had checked all monitors; all were found to be in good working condition.The biomed team also had a simulator so an additional investigation was possible.With the use of two simulators and set-ups, it was possible to conduct additional trouble shooting and narrow the failure to the cable.As a result of the testing, 4 cables were found to be faulty.The root.

Event Description

Cause of the reported failure was related to worn out monitor cables that lead to a poor connection and therefore no reading.There have been no design changes to this product within the past year that would contribute to any increased probability for no reading.Production controls are in place to reduce and/or eliminate the possibility of electrode problems that could lead to latent issues such as no reading.Since this complaint is unconfirmed from the manufacturing perspective but were external assignable causes as of the faulty monitor cables found at the hospital a corrective action of identifying the cables with a unique identifier would help track the movement and duration of use in the unit.In addition, it was recommended that cleaning and handling instructions be provided to the unit to ensure proper handling.This complaint will be recorded for tracking and trending purposes.A corrective action is not deemed necessary at this time.This complaint will be recorded for tracking and trending purposes.

• Brand Name: FSE 2100 SAFELINC SGL HEL 50/C
• Type of Device: FETAL ELECTRODE
• Manufacturer (Section D): COVIDIEN; 215 herbert street; gananoque ; CA
• Manufacturer (Section G): COVIDIEN; 215 herbert street; gananoque ; CA
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5094973
• MDR Text Key: 26647256
• Report Number: 9681860-2015-00007
• Device Sequence Number: 1
• Product Code: HGP
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 31479549
• Device Catalogue Number: 31479549
• Device Lot Number: 507108X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1