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

Model Number MODEL 100

Device Problem Display Difficult to Read (1181)

Patient Problem No Patient Involvement (2645)

Event Date 03/19/2019

Event Type  malfunction  

Manufacturer Narrative

The reported event of "the user observed broken lcd display on the autopulse platform (sn (b)(4)) and the display was not readable" was confirmed during visual inspection.The most possible root cause for the reported issue was due to user mishandling.Upon visual inspection, observed broken and not readable lcd display and scratched user interface (ui) membrane.Unable to perform functional testing due to user advisory (ua) 45 (not at "home" position after power-on/restart) error message displayed upon powering on the device.The encoder drive shaft was not within the normally acceptable range when powered on.The drive shaft was returned to home position using the administrative menu.Upon customer approval, the defective parts will be replaced and the autopulse platform will be further tested to full specification.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse platform with serial number (b)(4).

Event Description

During training, the user observed broken lcd display on the autopulse platform (sn (b)(4)) and the display was not readable.No patient involvement.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION INC; 2000 ringwood avenue; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION INC; 2000 ringwood avenue; san jose CA 95131
• Manufacturer Contact: kimthoa nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4085411030
• MDR Report Key: 8506335
• MDR Text Key: 141740351
• Report Number: 3010617000-2019-00276
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000536
• UDI-Public: 00849111000536
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2019
• 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: 8700-0730-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2011
• 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