MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEEL SNUGGLER - 4 BOXES OF 25/CASE

Model Number 99047

Device Problem Material Rupture (1546)

Patient Problem Injury (2348)

Event Type  Injury  

Event Description

The customer reported that the heel warmer ruptured and caused harm to the infant patient.Based on the limited information provided, this is being considered a serious injury, as it was stated that there was harm to the patient.

Manufacturer Narrative

(b)(4).A follow up report will be submitted once the investigation is complete.

Manufacturer Narrative

Multiple attempts (a total of 4) were made to obtain additional information about the reported incident and to obtain the product back for evaluation.The customer has not replied to any of these requests.Therefore, we are considering this to be a malfunction of insufficient information/unknown cause for reporting purposes only.The customer has been sent replacement product.The faulty product remains at the customer site.A search in oneems found no further related calls, suggesting the reported problem has not recurred.The investigation did not determine whether the product caused or contributed to the reported patient outcome because the customer did not respond to multiple attempts for additional information.

Event Description

Philips healthcare received a complaint stating that the product burst upon activation and caused harm to an infant.It was reported that the product caused harm to the patient; however the customer has not replied to attempts made by philips to get more information on what the harm was or if medical intervention was required.

• Brand Name: HEEL SNUGGLER - 4 BOXES OF 25/CASE
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd.; andover MA 01810
• Manufacturer Contact: wendy chadbourne ; 3000 minuteman road; andover, MA 01810 ; 9786597804
• MDR Report Key: 4723750
• MDR Text Key: 5748078
• Report Number: 1218950-2015-02148
• Device Sequence Number: 1
• Product Code: MPO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040044
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/13/2015

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?: No
• Device Operator: Health Professional
• Device Model Number: 99047
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/13/2015
• Initial Date FDA Received: 04/20/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/31/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1