MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS AVALON FM20 FETAL MONITOR

Model Number M2702A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Rash (2033)

Event Date 07/23/2015

Event Type  Injury  

Manufacturer Narrative

This complaint has been evaluated to be reportable as a patient harm (serious injury - irritation on the patient's skin - rash) was reported.Philips is in the process of obtaining additional information regarding this incident and the complaint is still under investigation.A final report will be submitted once the investigation is completed.(b)(4).

Event Description

The customer reported that "on the (b)(6) 2015, where toco and us transducer had been attached, the patient skin developed a rash.The customer applied rinderon to the rash.

Manufacturer Narrative

The device has not been made available to philips for evaluation; however, pictures were provided to confirm the rashes allegedly experienced by the patient due to the transducers.The patient experienced rashes from the transducers.No serious injury / adverse event was reported.The reported problem was resolved by providing information from the ifu to the customer in order to prevent such rashes from occurring.Instructions for use (ifu) were referenced to indicate proper usage of transducers so that such rashes can be avoided.The product remains at the customer site.The reported problem is consistent with misuse of the transducers; however, the information provided is not sufficient to completely rule out a product malfunction.The available information from this report does not support that this issue represents a systemic, design, or labeling problem.There is minimal health risk.No further investigation or action is warranted.

• Brand Name: AVALON FM20 FETAL MONITOR
• Type of Device: FETAL MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; böeblingen 71034 ; GM 71034
• Manufacturer Contact: wendy chadbourne ; 3000 minuteman road; andover, MA 01810
• MDR Report Key: 5024974
• MDR Text Key: 23848436
• Report Number: 9610816-2015-00182
• Device Sequence Number: 1
• Product Code: HGM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K052795
• 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: 08/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M2702A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2014
• 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
• Patient Outcome(s): Other