MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® RESUSCITATION 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 03/12/2015

Event Type  malfunction  

Event Description

It was reported during a shift check, that the back lighting of the lcd display of the autopulse platform, was not working properly and the data was difficult to read.There was no report of any patient involvement.No further information was provided.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned to the manufacturer for evaluation.Visual inspection was performed and no external damages were observed.The reported complaint however was confirmed; the display backlight was not functioning properly which resulted in the display being difficult to read.Further inspection identified the cause to be a defective processor pca assembly.Compression testing was performed with a test mannequin for 10 minutes and no user advisories or warnings were displayed.With the exception of the previously observed dark display, the platform performed as intended during functional evaluation.The platform archive was reviewed and no user advisories or warnings were observed on the reported event date.Based on the investigation, the part identified for replacement was the processor pca assembly.In summary, the reported complaint of the lcd display not functioning properly was confirmed during visual inspection and is attributed to the defective processor pca assembly.Following service, including replacement of the pca assembly, the device passed all testing criteria.

• 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: 4655175
• MDR Text Key: 5734680
• Report Number: 3010617000-2015-00201
• 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: 03/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2015
• 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: 03/19/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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