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

Model Number MODEL 100

Device Problems No Display/Image (1183); Device Inoperable (1663); Device Displays Incorrect Message (2591)

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

Event Date 09/16/2014

Event Type  malfunction  

Event Description

Complainant alleged that during a shift check, the autopulse® platform would not work at all and the lcd screen was blank.Zoll field rep visited the customer and indicated that the device now shows an "out of service, revert to manual cpr" message, upon power up.There was no report of any patient involvement.No further details were provided.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned to the manufacturer for evaluation.No batteries were returned for evaluation.Visual inspection of the returned platform was performed and found the following: the front enclosure was cracked and the battery lock was missing.From the condition of the platform, the damage appears to have been due to wear and tear.The platform was functionally tested and the reported issue that the "platform was not functioning and the lcd display was blank" could not be reproduced.The device was powered on/off multiple times and the display contrast, backlight and pixels all functioned as intended.During testing however, the reported error code 132 (internal watchdog timeout)," system error-out of service, revert to manual" message was observed.The fault was cleared and the platform was power cycled multiple times and no errors were displayed.Following clearing of the fault, the platform was run with a test mannequin and no problems encountered.A review of the archive showed the reported error 132 occurring on the reported event date of (b)(6)2014.No other advisories were noted on the reported event date.Based on the investigation, the parts identified for replacement were the front enclosure and battery lock.In summary, the reported complaint could not be reproduced.The reported issue of the platform displaying an error 132 was confirmed during functional evaluation as well as through archive review.Following clearing of the fault and replacement of the damaged and missing parts identified during visual inspection, the device passed all testing criteria.

• 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: 4215649
• MDR Text Key: 4971352
• Report Number: 3010617000-2014-00574
• 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,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2014
• 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: 10/14/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2010
• 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