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

Model Number MODEL 100

Device Problems Break (1069); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 06/05/2015

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform was returned to zoll (b)(4) for investigation on (b)(6) 2015.Investigation results as follows: visual inspection of the returned platform was performed and found that the patient head restraints were damaged, thus confirming the customer's reported complaint.In addition, the short black cover was also observed to be damaged.The physical damages found during visual inspection are attributed to normal wear and tear.When the platform was powered on during functional testing, it displayed a user advisory (ua) 17 (max motor on time exceeded during active operation) message.A brake gap inspection was performed which confirmed that the brake gap was out of specification and could not be adjusted back within specification.Therefore, the drive train motor was replaced to remedy this issue.A review of the platform's archive data was performed and found that multiple user advisory (ua) 17 messages occurred on the reported event date of (b)(6) 2015.A user advisory (ua) 18 (max take-up revolutions exceeded) was also observed on the same date.Based on the investigation, the parts identified for replacement were the patient restraint wires, short black cover and the drive train motor.In summary, the customer's initial reported complaint that the patient's head restraint wires were damaged was confirmed through visual inspection.The root cause was determined to be normal wear and tear.Unrelated to the initial reported complaint, ua 17 was observed during power on of the platform as well as in the platform's archive.The ua 17 fault was attributed to the drive train motor being defective.A ua 18 was also observed in the archive on the reported event date.A root cause for the ua 18 could not be determined, however a ua 18 is an indication that the autopulse has detected that either the patient's chest is too small while sizing the patient (take-up) or that there is no patient on the platform.Following service, including replacement of the damaged parts, the device passed all testing criteria.

Event Description

It was initially reported that the patient head restraint wires on the autopulse platform were damaged.No patient involvement was reported.No further information was provided.The autopulse platform was subsequently returned to zoll for investigation.During investigation, the autopulse platform displayed a user advisory (ua) 17 (max motor on time exceeded during active operation) message.Although the customer did not report this, ua 17 is considered a reportable malfunction.

• Brand Name: AUTOPULSE® RESUSCITATION SYSTEM 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: 5109114
• MDR Text Key: 27018187
• Report Number: 3010617000-2015-00532
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Report Date: 06/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2015
• 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: 06/05/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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