MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS ULTRASOUND TRANSDUCER FOR USE WITH FM20/FM30 AVALON

Model Number M2736A

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/02/2019

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.Date of incident has been requested not available at time of report.

Event Description

The customer reported that the report outlines that a fetal heart recording of 192 beats per minute (bpm) was provided by the fetal monitor fm30 and a decision was made to perform a caesarean section.However, upon auscultation it was found to be 80 bpm.A decision was made to perform a caesarean section.It is unknown, if there was any harm to the patient or user.

Manufacturer Narrative

H3 and h6: the third party evaluated the transducer and found that a non-philips cable was used.Based on the available information and the evaluation results obtained, the reported issue is not related to a malfunction of the transducer, but to the use of a non-philips cable instead.The customer was instructed to only use philips-approved accessories.The device worked as intended and there was no malfunction of the device.No further investigation or action is warranted.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: ULTRASOUND TRANSDUCER FOR USE WITH FM20/FM30 AVALON
• Type of Device: ULTRASOUND TRANSDUCER
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 9575291
• MDR Text Key: 174656258
• Report Number: 9610816-2020-00015
• Device Sequence Number: 1
• Product Code: HGM
• UDI-Device Identifier: 00884838000414
• UDI-Public: (01)00884838000414
• Combination Product (y/n): N
• PMA/PMN Number: K062137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 01/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M2736A
• Device Catalogue Number: 862199
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 32 YR
• Patient Weight: 91