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

Model Number 866075

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

Patient Problem Burn, Thermal (2530)

Event Type  Injury  

Manufacturer Narrative

Follow up report will be submitted once the investigation is complete.

Event Description

The customer reported a health damage in ctg use.Burn or redness.The customer reported a serious injury.No further details regarding the patient had been provided at the time the reporting decision was due.

Event Description

The customer reported a health damage in ctg use.Burn or redness.As a result of further investigation it was found that there was no serious injury to the patient as originally had been alleged.It was confirmed that the patient had redness only to the skin.

Manufacturer Narrative

A philips field service engineer (fse) went onsite to further investigate the reported issue.The customer stated that the patient came to do a check at the end of the pregnancy and sustained redness to the skin under the avalon cl toco+ mp transducer.As a result of the investigation it was found that there was no serious injury as the patient only had redness of the skin and no medication was necessary to treat the patient.No permanent damage to the skin was sustained.During the investigation, it was determined that the serial number initially provided for the transducer was incorrect and the correct number was (b)(6).The customer stated that mild soap and water only were used to clean and disinfect the device and that no residue of any disinfectant was on the transducer.The fse provided a photo of the transducer indicating an area that looked like a ¿crack¿ in the housing.This photo was forwarded to philips product support engineering (pse) who stated that the indicated area was not a ¿crack¿, but rather one of two intended infrared light eyes at the bottom of the transducer.Based on the available information, the exact cause for the reported issue could not be established.To resolve the issue at the customer site, the fse replaced the transducer.This issue was resolved by the replacement of the avalon cableless toco+ mp transducer (866075).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)
• Type of Device: PERINATAL MONTIORING SYSTEM
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 10179223
• MDR Text Key: 196005316
• Report Number: 9610816-2020-00209
• Device Sequence Number: 1
• Product Code: HGM
• UDI-Device Identifier: 00884838000414
• UDI-Public: (01)00884838000414
• Combination Product (y/n): N
• PMA/PMN Number: K140535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 06/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 866075
• Device Catalogue Number: 862199
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other