MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEARTSTART ADULT MULTIFUNCTION PADS PLUS; ELECTRODE PADS

Model Number M3713A

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Tissue Damage (2104)

Event Date 03/27/2018

Event Type  Injury  

Manufacturer Narrative

Cannot confirm serial number.A follow-up report will be submitted upon completion of the investigation.Additional information has been requested but not yet provided.

Event Description

It was reported to philips that the device was connected to the patient with m3713a heartstart adult pads plus, expiration date (b)(6) 2019.When the clinicians removed the pads, the patient's skin showed significant blistering that required treatment.The patient involved was reported to have been harmed by the pads adhesive.

• Brand Name: HEARTSTART ADULT MULTIFUNCTION PADS PLUS
• Type of Device: ELECTRODE PADS
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: robert corning ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 7432148
• MDR Text Key: 105513346
• Report Number: 1218950-2018-03410
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K002806
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/06/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: M3713A
• Device Lot Number: 011218-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/06/2018
• Initial Date FDA Received: 04/16/2018
• Supplement Dates Manufacturer Received: 04/06/2018
• Supplement Dates FDA Received: 09/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 48 YR
• Patient Weight: 100