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

Model Number MODEL 100

Device Problems Component Falling (1105); Failure to Power Up (1476)

Patient Problem No Patient Involvement (2645)

Event Date 04/22/2015

Event Type  malfunction  

Event Description

It was reported that during a morning check, the on/off switch fell inside of the autopulse platform.As a result, the device was unable to power on.No patient involvement was reported.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 which found that the on/off switch was not in the proper location.Thus confirming the customer's reported complaint.The load plate cover and multiple screw posts at the front enclosure and channel roller assembly were also observed to be damaged.The battery locking pin was bent and the front enclosure was cracked.The platform underwent initial functional testing and no faults or errors were exhibited.A review of the platform's archive was performed which found that no anomalies or errors occurred on the reported event date of (b)(6) 2015.Based on the investigation, the parts identified for replacement were the pla bracket-power button, top cover, load plate cover, battery lock pin and front enclosure.The platform underwent and passed all final functional testing.In summary the customer's reported complaint was confirmed through visual inspection of the platform.The root cause of the damage was determined to be normal wear and tear, as the pla bracket has never been replaced.After servicing, the platform passed all final 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: 4779711
• MDR Text Key: 5877807
• Report Number: 3010617000-2015-00281
• 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: 04/23/2015

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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/23/2015
• Initial Date FDA Received: 05/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2007
• 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