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

Model Number MODEL 100

Device Problems Break (1069); Component Missing (2306); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 05/28/2015

Event Type  malfunction  

Event Description

It was reported that during a daily check, the autopulse platform displayed a user advisory (ua) 2 (compression tracking error) message.Customer also reported that both of the head restraints were damaged and that the load plate screws were missing.No patient involvement was reported.No further information was provided.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 06/03/2015 for investigation.Investigation results as follows: visual inspection of the returned platform was performed and found that the head restraint wires were cut, the load plate screws were missing and the front and bottom enclosures were damaged.The customer's reported complaint that the head restraints were damaged and that the load plate screws were missing was confirmed through visual inspection.The other physical damages found during visual inspection are unrelated to the reported complaints.It should be noted that normal wear and tear can be expected since the autopulse was manufactured in july of 2007.A review of the platform's archive data was performed and found no faults or error messages on the reported event date of (b)(6) 2015; however, the archive data revealed that multiple user advisory (ua) 2 (compression tracking error) messages and one ua 12 (lifeband not present) message occurred on (b)(6) 2015, thus confirming the customer's reported complaint of a ua 2 message.The ua 12 message is unrelated to the reported complaint.The customer's reported complaint of a ua 2 was also replicated during functional testing.The returned platform performed a few compressions and then displayed a ua 2 message.The platform also intermittently displayed a ua 17 (max motor on time exceeded during active operation) message during testing.The software that was used to download the platform's archive data indicated that a load cell single point was not functioning.The load cell was replaced, after which, functional testing was continued.However, the platform displayed another ua 2 during compression testing.Further investigation identified a defective drivetrain.Based on the investigation, the parts identified for replacement were the load cell single point, the drivetrain, the top cover (including both head restraints), the load plate screws, the front enclosure and the bottom enclosure.In summary, the customer's reported complaint of damaged head restraints and missing load plate screws was confirmed during visual inspection.The root cause of the damaged head restraints and missing load plate screws could not be determined.Unrelated to the reported complaint, visual inspection also found that the front and bottom enclosures were damaged.It should be noted that normal wear and tear of the platform can be expected since the platform was manufactured in july of 2007.The customer's reported complaint of a ua 2 was confirmed during review of the platform's archive data.Furthermore, the ua 2 was replicated during functional testing.The root cause was determined to be a defective drivetrain.Unrelated to the reported complaint, a ua 17 also occurred intermittently during testing.The drivetrain was replaced to address both the ua 2 and ua 17 messages.Unrelated to the reported complaint, review of the archive data also found a ua 12 on the reported event date.There were no device deficiencies found during investigation which could have caused or contributed to the ua 12.Per the autopulse maintenance guide (p/n: (b)(4)), user advisory 12 is an indication that the autopulse has detected that the lifeband is not properly installed.The recommended actions to take for this type of user advisory are: ensure that the band clip (underneath the device) is properly seated in the drive shaft and the drive shaft can freely rotate after insertion.After replacement of all the parts identified during investigation, the platform passed all final functional 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: 4864420
• MDR Text Key: 5851196
• Report Number: 3010617000-2015-00356
• 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: 05/28/2015

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: 06/03/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/28/2015
• Initial Date FDA Received: 06/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2007
• 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