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

Model Number MODEL 100

Device Problems Device Issue (2379); Device Operates Differently Than Expected (2913)

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

Event Date 01/22/2016

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned to zoll for evaluation on february 5, 2016.Investigation results as follows: device history record (dhr) was reviewed and no previous related complaint was reported for this autopulse platform (s/n (b)(4)).Visual inspection of the returned platform was performed and upon power-up, the display was observed to be distorted.Additionally, the battery lock clip was bent and the front enclosure was damaged.The autopulse platform is a reusable device and was manufactured on october 2007.Therefore, this type of physical damages found during visual inspection is characteristic of normal wear and tear for the life of the device and is unrelated to the reported complaint.A review of the archive was performed and no discrepancies were observed.Upon power up the autopulse screen was distorted and looked like it was displaying a different language.Therefore, functional testing could not be performed.The distorted screen was attributed to a defective lcd display.Based on investigation, the lcd display, bent battery lock clip, and damaged front enclosure were replaced.Additionally, as a routine service, the power distribution board was also replaced.In summary, the reported complaint was confirmed during visual inspection and functional testing.The root cause for the distorted autopulse display screen was the defective lcd screen.After replacement of the parts identified during investigation, the platform passed all final functional testing criteria.A definitive root cause for the defective lcd display could not be determined.All autopulse platforms go through a thorough inspection and test prior to and during final inspection to ensure visual, structural, and functional integrity.Therefore, the defective lcd screen could potentially be due to normal wear and tear and/or physical abuse.Additionally, a li-ion battery (s/n(b)(4)) returned with the platform was successfully charged and passed charger testing indicating that the distorted lcd screen was not due to battery issues.

Event Description

A zoll representative reported that the autopulse screen displayed characters that looked like a different language.No other information was provided.No patient involvement was reported.

• 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: 5461156
• MDR Text Key: 39087329
• Report Number: 3010617000-2016-00091
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000277
• UDI-Public: 00849111000277
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/18/2016

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
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0700
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/22/2016
• Initial Date FDA Received: 02/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2007
• 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