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 12/07/2016

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform (s/n: (b)(4)) was returned to zoll for evaluation.The primary complaint was confirmed during functional testing.The display was found to function intermittently.The root cause was found to be a faulty lcd display.The autopulse platform is a reusable device and was manufactured on 09/25/2008.Therefore, this type of display issue is characteristic of normal wear for the life of the device.To resolve the primary issue the lcd was replaced.Visual inspection was performed and found (unrelated to the reported complaint) the top cover and front enclosures cracked, and the battery lock bent.Further evaluation also found a sticky clutch and discrepancy between load cells 1 and 2.To ensure that the autopulse platform is functional without issue, the damaged parts observed during visual inspection and evaluation were replaced.Additionally, the power distribution board was updated, to ensure the platform remains current.No issues were found during review of the archive data.Historical complaints were reviewed for service information related to the reported complaint and (b)(4) was reported for a partially readable display with serial number (b)(4).The platform passed all final testing criteria.

Event Description

During a shift check, after the autopulse platform (s/n: (b)(4)) was powered on, it was reported that the platform display was either blank or unreadable.Despite replacing the battery, the display issue continued.There is 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: 6214805
• MDR Text Key: 63619159
• Report Number: 3010617000-2016-00942
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• 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,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/29/2016

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: 12/14/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/08/2016
• Initial Date FDA Received: 12/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2008
• 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