MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS AVALON FM50 FETAL MONITOR

Model Number M2705A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Abrasion (1689); Erythema (1840)

Event Date 07/23/2014

Event Type  Injury  

Event Description

The customer reported that after having been in contact with avalon transducer, the pt developed redness.The customer removed the us cable and used another one.They followed up with the pt the next day in order to assess her abdomen.It had 2 red areas, approximately 1-2cm each in length.One was reddened.The other looked like an abrasion.The customer contacted the skin care rn and notified the physician.

Manufacturer Narrative

(b)(4).A follow up report will be submitted after phillips obtains more info concerning this event.

• Brand Name: AVALON FM50 FETAL MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 7103 4; GM 71034
• Manufacturer Contact: denyse murphy ; 3000 minuteman rd.; andover, MA 01810 ; 9786597844
• MDR Report Key: 4071975
• MDR Text Key: 4898704
• Report Number: 9610816-2014-00206
• Device Sequence Number: 1
• Product Code: HGM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071800
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M2705A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/23/2014
• Was Device Evaluated by Manufacturer?: No
• 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