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

Model Number	MODEL 100
Medical Device Problem Code	Display Difficult to Read (1181)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/19/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION INC; 2000 ringwood avenue; san jose CA 95131
• MDR Report Key: 8506335
• Report Number: 3010617000-2019-00276
• Device Sequence Number: 198263
• Product Code: DRM
• UDI-Device Identifier: 00849111000536
• UDI-Public: 00849111000536
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2019
• Initial Report FDA Received Date: 04/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1