MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® RESUSCITATION SYSTEM MODEL 100; CARDIAC CHEST COMPRESSOR

Model Number MODEL 100

Device Problem Material Separation (1562)

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

Event Date 07/10/2015

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform ((b)(4)) was returned on 7/8/2015 to zoll for evaluation.Investigation results are as follows: visual inspection was performed and the reported problem of the rubber piece of the load sensor separating from the platform was observed, thus confirming the customer's reported complaint.The load plate cover santoprene needed to be replaced.From the condition of the platform, the damages appear to have been caused by normal wear and tear (autopulse manufactured 5/2011).No other damages to the autopulse platform were observed.The platform was functionally tested and during testing with a large resuscitation test fixture (equivalent to 250 pound patient), the autopulse platform displayed a user advisory (ua) 2 (compression tracking error) message.In addition, the platform underwent load cell characterization testing and further inspection identified that both load cells were defective and not functioning correctly.Unrelated to the reported complaint, the clutch plate needed be deburred as a result of the sticky spool shaft.Following replacement of both load cells and deburring the clutch plate, the platform passed all final functional testing.A review of the archive was performed and no user advisory or warning messages were observed on the reported event date of (b)(6) 2015.Based on the investigation, the parts identified for replacement were the load plate cover santoprene and both load cells.In summary, the reported complaint of the rubber piece of the load sensor separating from the platform was observed and is attributed to wear and tear.The load plate cover was replaced to remedy the reported problem.Unrelated to the reported complaint, the platform displayed a ua2 during functional testing as a result of both load cells being defective.Following replacement of the load cells, the platform passed functional testing.Following service, the platform passed all testing criteria.

Event Description

It was initially reported that on (b)(6) 2015, during a training it was observed that the rubber piece on the load sensor separated from the autopulse platform.No patient involvement was reported.No further information was provided.The autopulse platform was subsequently returned to zoll for investigation.During investigation, the autopulse platform displayed a user advisory (ua) 2 (compression tracking error) message.Although the customer did not report this, ua 2 is considered a reportable malfunction.

• Brand Name: AUTOPULSE® RESUSCITATION SYSTEM MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 4948150
• MDR Text Key: 23042409
• Report Number: 3010617000-2015-00435
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Report Date: 06/26/2015

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 Model Number: MODEL 100
• Device Catalogue Number: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2011
• 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