MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS AVALON CL TOCO + MP TRANSDUCER (AS ON DOC); PERINATAL MONTIORING SYSTEM

Model Number	866075
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
Event or Problem Description
The customer reported that after childbirth, there was a large wound found on mother's belly.It is difficult to determine if it was caused by pressure, heat or hypersensitivity.There was a continuous registration for 17 hours, and it is unclear if the transducer was repositioned.The wound was discovered in connection with the post care a few hours after birth.
Additional Manufacturer Narrative
H3 and h6: the customer received support from their distributor service engineer who found with the customer that the av cl toco+ mp transducer did not show any damage.It is unknown if the avalon cl toco+ mp transducer was repositioned and the skin at the application site was regularly verified, during the 17 hours in use, as described in the instruction for use from philips.The reported patient's wound was treated with gel, no further treatment is planned or required.The distributor service engineer worked with the customer remote and provided instructions for use to the customer.Due to the lack of available information, a clear cause for the reported issue could not be established and a malfunction of the device cannot be ruled out.The reported av cl toco+ mp transducer remains at the customer site.Response with instructions was provided per email 20-april-2020 to the initiator of this cfs to provide to the customer.No further investigation or action is warranted and requested from the initiator.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: AVALON CL TOCO + MP TRANSDUCER (AS ON DOC)
• Common Device Name: PERINATAL MONTIORING SYSTEM
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 9784993
• Report Number: 9610816-2020-00072
• Device Sequence Number: 16768235
• Product Code: HGM
• UDI-Device Identifier: 00884838034235
• UDI-Public: (01)00884838034235
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 866075
• Device Catalogue Number: 866075
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/11/2020
• Supplement Date Received by Manufacturer: 02/11/2020
• Initial Report FDA Received Date: 03/04/2020
• Supplement Report FDA Received Date: 04/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other