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

Model Number MODEL 100

Device Problem No Display/Image (1183)

Patient Problem No Patient Involvement (2645)

Event Date 06/24/2016

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned to zoll for evaluation.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse with serial number (b)(4).Visual inspection of the returned platform was performed and found that the top cover, front enclosure, bottom enclosure and battery lock were damaged.Additionally only half of display was working thus confirming the reported complaint.The autopulse platform is a reusable device and was manufactured on 03/04/2008.Therefore, this type of physical damages found during visual inspection is characteristic of normal wear and tear for the life of the device and is not related to the reported complaint.A review of the platform archive was performed and there were no problems found in the internal log.The platform was functionally tested and there were no problems or error messages noted.Unrelated to the reported complaint, further testing showed that the drive shaft was stiff when rotated.The clutch plate was deburred to address the stiff drive shaft.In summary the customer's reported complaint that the half of the platform display was working was confirmed during visual inspection but not during functional testing.The lcd display was replaced.There were no device deficiencies found during evaluation of the returned platform that could have caused or contributed to the reported complaint.Therefore, the exact root cause could not be determined.After replacing the lcd display, the platform passed all final functional testing criteria.

Event Description

The customer reported that during shift check, the crew observed that only half of the autopulse lcd display powers up.The platform was powered off and on and the same issue was observed.There was no patient involvement reported.

• Brand Name: AUTOPULSE® RESUSCITATION 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: 5807535
• MDR Text Key: 49946307
• Report Number: 3010617000-2016-00506
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• 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,other
• Reporter Occupation: Paramedic
• Type of Report: Initial
• Report Date: 07/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Paramedic
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2008
• 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