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

Model Number MODEL 100

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 12/12/2014

Event Type  malfunction  

Event Description

It was initially reported that during a shift check on (b)(6) 2014, the housing of the autopulse was damaged at the seam between the top and bottom halves of the device.No patient involvement 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 multiple user advisory (ua) 12 (lifeband® not present) codes occurred on the reported event date of (b)(6) 2014.Although the customer did not report this, ua 12 is considered to be a reportable malfunction.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned for evaluation.Visual inspection was performed and the reported complaint of the platform covers being damaged was confirmed.The following damages were observed: the patient restraint pin, encoder cover, motor cover, top cover, and battery compartment were damaged.A screw was also found to be missing at the encoder cover.From the condition of the returned unit, the cause of the damages appeared to be wear and tear.The platform was run with a large resuscitation test fixture (equivalent to a (b)(6)patient) for 15 minutes and no problems were found.The platform passed functional test requirements.A review of the archive was performed which showed that on the reported event date of (b)(6) 2014, multiple user advisory 12 codes (lifeband not present) occurred.There were no mechanical issues or damages observed with the platform that could have caused or contributed to the observed ua 12 codes.Based on the archive data, the cause of the codes was likely that the belt clip was not detected in the spool shaft due to improper installation of the lifeband.Based on the investigation, the part(s) identified for replacement were the following: patient restraint pin, encoder cover, motor cover, top cover, battery compartment, and missing screw at the encoder cover.In summary, the reported complaint was confirmed during visual inspection and attributed to wear and tear.Unrelated to the reported event, multiple ua 12 faults were observed on the reported event date and of (b)(6) 2014 and likely attributed to improper installation of the lifeband.There were no mechanical issues or damages observed with the platform that could have caused or contributed to the observed ua 12 codes.

• 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: 4429911
• MDR Text Key: 5171162
• Report Number: 3010617000-2015-00044
• 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: 12/12/2014

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: 12/17/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/14/2015
• Initial Date FDA Received: 01/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2006
• 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