MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AVCL-TOCO REPLACEMENT XDR ISM

Model Number 453564423311

Device Problem Defective Alarm (1014)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/22/2023

Event Type  malfunction  

Manufacturer Narrative

The remote service engineer (rse) determined the cause of the reported problem was the transducer.The reported problem was confirmed.The rse determined that the transducer required replacement.The customer was provided a replacement transducer to resolve the issue.If additional information is received the complaint file will be reopened.

Event Description

Philips received a complaint on the avcl-toco replacement xdr ism indicating that the cl transducer led turns cyan, with an intermittent audible alarm.It was reported that the avalon cl base did not detect this transducer, and there was no inop message on the monitor to state the battery on this transducer was empty.The device was in use at time of event, there was no adverse event reported.

• Brand Name: AVCL-TOCO REPLACEMENT XDR ISM
• Type of Device: AVCL-TOCO REPLACEMENT XDR ISM
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer Contact: hauke schik ; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034 ; 7031463203
• MDR Report Key: 18355845
• MDR Text Key: 330884271
• Report Number: 9610816-2023-00678
• Device Sequence Number: 1
• Product Code: HGM
• UDI-Device Identifier: 00884838034235
• UDI-Public: 00884838034235
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K140535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 453564423311
• Device Catalogue Number: 453564423311
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1