MAUDE Adverse Event Report: PHYSIO-CONTROL, INC LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR; DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)

Model Number 20

Device Problem Detachment Of Device Component (1104)

Patient Problem No Patient Involvement (2645)

Event Date 04/30/2014

Event Type  malfunction  

Event Description

The customer reported to a physio-control sales representative that when they tried to connect the defibrillation hard paddles to their device the metal plate detached from the hard paddles assembly.There was no patient use associated with the reported event.

Manufacturer Narrative

(b)(4).The device itself was not returned to physio-control for evaluation.The defibrillation hard paddles were returned to physio-control for evaluation.Physio-control continues to investigate the reported failure and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.

Manufacturer Narrative

Physio-control evaluated the defibrillator (hard) paddles assembly and verified the reported failure.It was observed that for both defibrillation paddles the metal electrode plate had separated from the plastic housing.On one defibrillation paddle rtv adhesive was visible on the metal plate and in each corner of the housing.A blue-green residue dispersed around the enclosure.On the second defibrillation plate rtv adhesive was visible in each corner of the housing and a blue-green residue dispersed around the enclosure.The metal plate detached because of a lack of a primer to help promote the adhesion of the rtv adhesive to the abs plastic of the paddle assembly.The customer was advised to order a new defibrillator (hard) paddles assembly.

• Brand Name: LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR
• 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 970
• Manufacturer (Section G): PHYSIO-CONTROL, INC; 11811 willows road ne; po box 97006; redmond WA 98073 970
• Manufacturer Contact: jason march ; 4258674000
• MDR Report Key: 3834590
• MDR Text Key: 4395635
• Report Number: 3015876-2014-00591
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K063119
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 20
• Device Catalogue Number: 3202488
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: 8 YR
• Event Location: Hospital
• Date Manufacturer Received: 08/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2005
• 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