MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH PHILIPS M2734B SMART TOCO TRANSDUCER

Model Number FFPH3505-B

Device Problem Circuit Failure (1089)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The complaint device was returned for evaluation.Incoming visual inspection found that the case was chipped.Technical visual inspection found that the casing and cable were in fair condition.Device evaluation identified that the cable was working properly.Additionally, there was an internal short on the integrated circuit of the mainboard causing the malfunction, confirming the reported malfunction.The integrated circuit on the main board was replaced.Gain measurement was performed.Parameter testing was performed and passed.Cable, membrane, and the shake/rattle tests were performed and passed as well.The reported event was confirmed.A definitive root cause for the internal short of the integrated circuit malfunction on the mainboard cannot be determined; however, it is most likely due to moisture or usage over time.This type of event will continue to be monitored.

Event Description

Reportedly, post repair an equipment malfunction was reported.There was no report of patient involvement.No additional information is available.

• Brand Name: PHILIPS M2734B SMART TOCO TRANSDUCER
• Type of Device: TRANSDUCER
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH; hewlett-packard-str.-2; boeblingen, 71034 ; GM 71034
• Manufacturer (Section G): AVANTE HEALTH SOLUTIONS; 212 avenida fabricante; san clemente CA 92672
• Manufacturer Contact: jenna vargas ; 212 avenida fabricante; san clemente, CA 92672
• MDR Report Key: 9251530
• MDR Text Key: 178000653
• Report Number: 3007409280-2019-00067
• Device Sequence Number: 1
• Product Code: HGM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 10/09/2019

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 Model Number: FFPH3505-B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/09/2019
• Initial Date FDA Received: 10/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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