MAUDE Adverse Event Report: PHYSIO-CONTROL, INC HANDLES AND CONNECTOR WITH DISCHARGE CONTROL FOR INTERNAL; DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)

Catalog Number 3006569

Device Problem Failure to Deliver Energy (1211)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/03/2015

Event Type  malfunction  

Manufacturer Narrative

Physio-control evaluated the internal defibrillation paddles and was unable to verify or duplicate the reported failure to deliver defibrillation energy.The cause of the reported issue could not be determined.

Event Description

The customer reported that during a patient event, the internal defibrillation paddles did not deliver defibrillation energy.The customer indicated that they attempted defibrillation delivery 3 or 4 times and then was able to use a back up set of internal defibrillation paddles successfully.The patient did not suffer any adverse outcome during the reported event.

• Brand Name: HANDLES AND CONNECTOR WITH DISCHARGE CONTROL FOR INTERNAL
• Type of Device: DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)
• Manufacturer (Section D): PHYSIO-CONTROL, INC; 11811 willows road ne; po box 97006; redmond WA 98073 9706
• Manufacturer (Section G): PHYSIO-CONTROL, INC; 11811 willows road ne; po box 97006; redmond WA 98073 9706
• Manufacturer Contact: jason march ; 4258674000
• MDR Report Key: 5040382
• MDR Text Key: 24581303
• Report Number: 3015876-2015-01050
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K895379
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Report Date: 08/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3006569
• Device Lot Number: 0105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/28/2015
• 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: Reuse
• Patient Sequence Number: 1