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 Known Impact Or Consequence To Patient (2692)

Event Date 02/15/2015

Event Type  malfunction  

Event Description

It was initially reported that during patient use, one of the head restraint wires of the autopulse® platform broke.No adverse patient sequelae was reported.No further information was provided.The autopulse platform was subsequently returned to zoll for investigation.During review of the platform's archive data, it was observed that the autopulse platform displayed a user advisory (ua) 2 (compression tracking error) message on the reported event date of 02/15/2015.Although the customer did not report this, ua 2 is considered a reportable malfunction.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 02/20/2015 for investigation.Investigation results as follows: visual inspection was performed and the reported complaint of one of the head restraint wires being broken was confirmed.The following damages to the platform were observed: the load plate cover was torn, one side of the head restraint wire strands was broken, and the battery lock clip, battery connector and front enclosure were damaged.Both shoulder screws were also found to be have been missing from the front and bottom enclosures.From the condition of the returned platform, the damages appear to have been due to wear and tear.The platform was run with a test mannequin for 15 minutes and no issues were observed.The platform performed as intended during functional evaluation.A review of the platform archive was performed which showed that multiple user advisory (ua) 2 (compression tracking error) codes occurred on the reported event date, as a result of the lifeband being opened while the device was powered on.Based on device inspection, there were no mechanical issues which could have caused or contributed to the observed ua codes.Based on the investigation, the part(s) identified for replacement were the top cover including load plate cover, broken battery lock clip, damaged battery connector and front enclosure as well as the missing shoulder screws.In summary, the reported complaint was confirmed during visual inspection and is attributed to wear and tear.Unrelated to the reported complaint, the archive showed multiple ua 2 codes occurring on the reported event date.From the data, it appears that the cause of the ua 2 codes was a result of the customer opening the lifeband while the device was powered on.Following service, including replacement of the damaged and missing parts, the device passed all testing criteria.

• 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: 4571105
• MDR Text Key: 5459820
• Report Number: 3010617000-2015-00143
• 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: 02/18/2015

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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2015
• Initial Date FDA Received: 03/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2008
• 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