MAUDE Adverse Event Report: COVIDIEN 33110E EU DISP 10 LEAD MONITORING SET X5; TRANSDUCER, MINIATURE PRESSURE

Model Number	33110E
Medical Device Problem Codes	Failure to Read Input Signal (1581); Illegible Information (4050)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Customer reports: when the customer used the cables to perform an ecg there are some artifacts and the result is not legible.Two cables from the same lot were used in the same patient with this problem.No patient injury.
Additional Manufacturer Narrative
The lot number was provided, and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.The manufacturing site has received two cable sets for the evaluation.Under current mass production test conditions, the site has performed the electronic test on the returned cables, the two cable sets passed the electronic test.From the investigation, the returned cables are functional.Based on the dhrs review, no change of material, tooling, process procedure and machine parameter were noted.The site has performed 100% functional test; the reported issue cannot be caused by manufacturing process before shipment.At this time, a corrective and preventive action is not deemed necessary.

• Brand Name: 33110E EU DISP 10 LEAD MONITORING SET X5
• Common Device Name: TRANSDUCER, MINIATURE PRESSURE
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11700972
• Report Number: 1282497-2021-10085
• Device Sequence Number: 19617458
• Product Code: IKE
• UDI-Device Identifier: 10884521516359
• UDI-Public: 10884521516359
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2021

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
• Operator of Device: No Information
• Device Model Number: 33110E
• Device Catalogue Number: 33110E
• Device Lot Number: 025170
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/19/2021
• Supplement Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 04/21/2021
• Supplement Report FDA Received Date: 07/19/2021
• Patient Sequence Number: 1