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 05/13/2016

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned to zoll for evaluation.Investigation results as follows: device history record (dhr) was 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 no physical damages to the autopulse platform.A review of the archive was performed and no discrepancies were observed.During functional testing the autopulse platform passed all functional tests without any discrepancies.Further testing showed that the backlight on the platform was not working and was attributed to a faulty processor board.In summary the customer's reported complaint is confirmed.The root cause for the display not to be clear and having intermittent backlight was due to a faulty processor board.After the part was replaced, the platform passed all final functional testing criteria.

Event Description

The customer reported that during shift check, the backlight on the autopulse platform was intermittently not working.The display was not clearly readable.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: 5705284
• MDR Text Key: 46760854
• Report Number: 3010617000-2016-00395
• 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: Health Professional
• Type of Report: Initial
• Report Date: 06/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2016
• 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: 05/19/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2014
• 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