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

Model Number MODEL 100

Device Problems No Display/Image (1183); Unable to Obtain Readings (1516)

Patient Problem No Patient Involvement (2645)

Event Date 04/07/2015

Event Type  malfunction  

Event Description

It was reported that during a shift check, the lcd display of the autopulse platform was intermittently flickering.When this occured the display was not readable.No patient involvement was reported.No further details were provided.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned to the manufacturer for evaluation.Visual inspection was performed and the following was observed: the bottom enclosure was damaged.From the condition of the platform, the damage appears to have been caused by normal wear and tear.Functional testing was performed and the reported complaint was confirmed; the platform's lcd display was found to be flickering.The lcd display was replaced to remedy this issue and following its replacement, the platform passed functional testing with no further issues observed.Unrelated to the reported complaint, a user advisory 18 (max take up revolutions exceeded) was observed on the reported event date.No device deficiencies were found with the platform that may have been contributory to the ua 18.A cause could not be determined, however the code likely occurred as a result of the customer attempting to retract the lifeband into a storage position.Based on the investigation, the parts identified for replacement were bottom enclosure and the lcd display.In summary, the reported complaint was confirmed based on functional evaluation and is attributed to the defective lcd display.Following service, the device passed all test 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: 4735146
• MDR Text Key: 5826734
• Report Number: 3010617000-2015-00256
• 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
• Type of Report: Initial
• Report Date: 04/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2015
• 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: 04/14/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2009
• 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